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Analytical Lab Team Leader
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Duration: 36 Months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
• Supervises the activities of QC Analytical Chemists and Lab Assistants.
• Performs final review of all Analytical test samples (components, raw materials, in-process bulk, finished product, commercial stability, method transfer, process validation, and cleaning validation) for the Lancaster facility and other affiliates so as to provide a high degree of assurance that all data is handled, managed, and released in a technically competent, compliant and efficient manner.
• This position requires thorough knowledge of domestic and international requirements, the ability to interact with other departments, and excellent written and oral communication skills. This position interacts with various internal departments and external divisions on a routine basis to coordinate manufacturing, release, stability, development, and validation efforts. Provides testing support in the QC Analytical Laboratory.
• This position substitutes for the Analytical Manager in his/her absence and acts as technical advisor for testing issues. "
• Experience in conducting laboratory investigations.
• Ability to lead and develop lab analysts.
• Must be professional and ethical in all activities and relations.
• Must demonstrate through example and maintain a positive attitude.
• Must exhibit the initiative to take on individual projects, eliminate roadblocks and see them through to completion.
• Capable of working both independently and as a team member.
• Ability to work and communicate well with personnel in different departments and at various levels of responsibility.
QUALIFICATIONS
• 3-5 years Pharmaceutical QC Analytical Laboratory experience.
• 2 years Pharmaceutical QC Analytical Laboratory supervision experience, preferred.
• Working knowledge and understanding of cGMP regulations as they relate to laboratory operations.
• Knowledge and experience with HPLC analysis. Experience with other instrumentation such as ICP, GC, and FTIR, preferred.
• BS or BA in Chemistry.
• BS or BA in a Science Field and appropriate experience
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Application Developer
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Duration: 9 months
Location: Cambridge,MA
Working within the Research and Development Information Solutions (R&D IS) team as an interface with both Scientists working in the R&D Global Bioinformatics and Genomics group and Global Infrastructure Services (GIS) in Information Solutions to provide application support on the High Performance Computing Cluster (HPCC) in the Discovery function at Company Biologics in Cambridge, MA.
• Implementing, testing and managing applications used by Scientists working in the R&D Global Bioinformatics and Genomics group. This group uses both commercial and proprietary scientific computing applications running on LINUX, Mac OS X, Solaris, and Windows.
• Resource will be responsible for providing application support, including building applications from source, managing the deployment and scheduling of software applications on the HPCC, migrating and configuring applications and ensuring inter-operability between applications.
• Providing effective communication between GIS (who provide LINUX, UNIX, Windows, and Oracle support), the R&D IS team, and the business users.
• Development and maintenance of standardized data management (loading, updates, maintenance) and support procedures for specific applications, for example, Biowisdom SRS.
• Providing training to users on specialized applications as needed.
• Participating in the development and approval of standardized documentation for these processes, following company documentation standards.
• Maintaining a high level of client satisfaction while meeting Service Level Agreement (SLA) guidelines.
• Resolving or escalating/monitoring Client Support Incidents and effectively communicating status, solutions and/or workarounds to clients.
• Properly documenting actions taken on all work for Client Support Incidents.
• Other specific projects to be defined by R&D IS management as needed.
DELIVERABLES
In addition to the project-specific deliverables described in the Scope of Work, the following deliverables may be required from the contractor for each project worked on:
Project Plan
A high-level project plan using Microsoft Project will be developed in the early stage of each project. The plan will list high level timelines and resource requirements. This plan will be further refined once the requirements document is complete. This plan will be reviewed and approved by a company R&D IS representative. If the contractor is not the project lead then they will provide input to this document.
Requirements Document
A requirements document will be developed in our IS eDoc document management system. This document will be developed through requirements gathering meetings with the business user and through requirements review sessions with the IS technical team. This document will be approved through the IS eDoc workflow process. If the contractor is not the project lead then they will need to provide input to this document
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CAPA Specialist III
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Duration: 36 Months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
• Responsible for driving results and ensuring the viability of the corrective and preventive action (CAPA) process at the Lancaster site.
• Responsible for the administration, effectiveness and continuous improvement of the CAPA process systems.
• Responsible for incorporating the CAPA results into the monthly quality forum.
• Responsible for interacting with other team members managing other aspects of the quality system
• Bachelor’s in Science degree with an emphasis in Biology, Chemistry, Microbiology, Engineering, Natural Science or related degree.
• Knowledge in cGMP (21 CFR parts 11, 210 and 211) and pharmaceutical industry applicable regulations.
• Knowledge in Process Excellence and Lean Six techniques.
• Advanced skills in statistical analysis are preferred. Experience with Microsoft Office applications.
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Complaint Specialist II
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Duration: 36 Months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
• The Complaint Specialist II is responsible for administration of the Customer Complaint Management system – collecting, monitoring, trending, prioritizing, coordinating investigations, and responding to customer complaints related to Company products.
• Complaints must be handled in a professional and timely manner in compliance with Current Good Manufacturing Practices (cGMP) and Company Standard of Procedure (SOP) requirements.
• Position accomplishes of day to day system administration activities, ensuring that complaints are investigated, processed, and closed in an expeditious fashion.
• Position is responsible for routine reporting of complaint data to Quality Management and Lancaster Staff, Annual Product Review (APR), Regulatory and Central QA Management.
• Work includes complaint functions at Lancaster plant site, with Central Quality, Medical Affairs and Consumer Relationship Center interface.
• Position may also be responsible for other QA work/functions in support of prioritized need by QA management.
• 3-5 years Quality experience in the regulated pharmaceutical industry.
• Consumer Affairs, Complaint Administration, or cGMP Compliance experience.
• Use of Product Quality Management System (PQMS).
• Working knowledge and skills related to the use of computer systems.
• Strong organizational skills.
• Strong communication skills.
• Must be independent worker and require minimal supervision to perform daily job functions. Must have appropriate sense of urgency and ability to raise issues to management, when necessary.
• Ability to work well with others to resolve problems.
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Compliance Specialist III Consultant
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Duration: 36 Months
Location: Lancaster PA
DESCRIPTION AND QUALIFICATIONS
• Responsible for providing daily compliance support to the Process Review Team (PRT) consistent with the supply chain’s goals, while meeting the compliance goals of Quality Assurance. This support includes both quality functions (online batch record review, review of the completed batch record, management of quarantined materials, etc.) and PRT functions (real-time compliance consulting, issue resolution, timely achievement of metrics). Support Quality Facilitator functions for event completion and review of GMP documentation.
• Demonstrated leadership- possesses the ability to lead a team
• Strong decision-making ability
• Asks the right questions to form appropriate decisions
• Gathers all relevant information and elevates issues appropriately
• Keen attention to detail
• Expertise in handling multiple priorities
• Demonstrated ability to maintain positive working relationships with others
• Must demonstrate firm conviction on regulatory boundaries, in the face of challenges and pressures while maintaining professionalism and diplomacy
• Demonstrated communication and organizational skills
• Strong appreciation for quality in the process and the product
• Demonstrated ability to own and resolve compliance issues or gaps
• Manufacturing Process Experience
• SOP author
• High Performer / SME
• Proficient in SAP, Word, Excel, EDM, Outlook
• 3-5 years Pharmaceutical GMP Experience in a Compliance Position
• B.S. or B.A. College Degree (Science or Technical Degree preferred)
• Demonstrate sustained performance through results (minimum of 2 years)
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Compliance Wire Administrator Consultant
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Duration: 12 Months
Location: Lancaster,PA
Administer all training in the Compliance Wire LMS, including setting up new users, creating curricula and user groups, loading content, and running reports, as well as managing hard copy training records.
Major Duties and Responsibilities:
Interface/communicate with functional area management for accurate group/individual training requirements
• Administer qualifications, components, content objects, catalogs, and learner records in the LMS
• Administer/maintain all training files: individual (active and inactive) and group (topic-specific)
• Administer all SOPs and non-SOP training components in LMS and audit for correct versioning and component information
• Respond to all LMS work requests and all inquiries regarding training
• records/reports
• Administer entry and removal of all hired/terminated personnel in the LMS
• Provide training/user support on the LMS
• Provide administrative support for all training courses/webinars, including electronic data entry of attendees, scheduling in LMS, updating the training calendar on the Sharepoint Site, and setting up Live Meeting when applicable
• Administer the storage of training materials in the online database and hard-copy
• Communicate training sessions to training audiences
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CSV Engineering Consultant(QSE 6 CSV )
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Duration: 12 Months
Location: Philadelphia Area
DESCRIPTION
Home Office Engineering representative on QSE6 Computer System validation work plan. Responsible for delivering a sustainable solution to work plan steps VL07, VL08, and VL09. Ensure Engineering voice is captured in the Computer system Validation to-be process. Ensure spreadsheets utilized for GxP purposes to manufacture McNeil products are identified and validated for their intended purpose. Work with the site engineering, CSV assessors, and auditors to identify, assess, and remediate legacy automation systems. Develop standard templates to ensure effective and efficient CSV of automated systems. Assist QSE9 with any applicable system integration design between shop floor systems and CMMS (SAP PM). Assist sites in maintaining existing manufacturing systems in a validated state as they relate to CSV.
Must be able to work Monday - Friday from 8am-5pm in Home Office except when traveling to manufacturing sites. Additional hours/days may be required during certain phases of this work.
• Must be able to travel as needed to manufacturing sites.
Ensure quality and compliance in all actions by:
o Attend GMP training on the schedule designated for role and as appropriate for role
o Adhere to strict compliance with procedures applicable to role.
o Exercise the highest level of integrity in the tasks performed
o In a timely and prompt manner, identify, report and seek correction for deviations noted in workplace.
o Embrace a behavior of involvement and commitment to doing the job right the first time
• Provide technical expertise to each manufacturing site to help determine standards following a strategic approach to any factory floor automation initiative. Additionally, provide technical support required by Engineering to fully and efficiently integrate the site's shop floor systems.
BS in Engineering
7-10 years of Control System and Automation engineering experience in a manufacturing environment. 5 Years of direct experience performing Computer System validation in an FDA regulated manufacturing environment. Preferred candidate will have Process Excellence certification.
Thorough understanding of control systems as they relate to manufacturing equipment (PLC, SCADA, HMI, Historian, Batch Engine). Detailed oriented quality minded individual with the ability to write and review Computer system validation documentation including Validation plans, requirement documents, design documents, test scripts, and summary reports in an FDA regulated manufacturing environment. Ability to create effective and efficient processes as related to CSV in a manufacturing environment.
• Ability to create standard templates for CSV of automated equipment in a manufacturing environment.
• Thorough understanding of MS Office applications and advanced functions in MS Excel.
• Ability to work in a team and lead a team.
• Ability to work with geographically diverse team that may not be co-located in one facility.
• Must be able to navigate through GMP manufacturing facilities
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Deactivation and Discontinuation Lead Consultant
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Duration: 12 Months
Location: Philadelphia Area
The Deactivation & Discontinuation Lead is responsible for is establishing a comprehensive, reliable, compliant process in accordance with the Standard (PD-003). This position is responsible for working under the direct supervision of a SME, trained on the current Deactivation & Discontinuation Standard. This position will interact with other QSE leads, as appropriate and align deliverables and interdependencies with other Numbered Steps. This position will report to the QSE 7 Lead. This position could require up to 30% travel.
Minimum of a bachelor's degree in a science or related field
• Minimum 5 - 8 years experience in a pharmaceutical or GMP regulated company required
• Demonstrated experience with Business Process Design and application of process excellence tools required
• Scientific training and fundamental understanding of pharmaceutical product manufacturing and planning
• Knowledge of Pharmaceutical manufacturing processes, cGMPs, ICH Guidelines, and cGLPs
• Strong verbal and written communication skills
• Demonstrated problem solving, decision making, negotiation/influencing skills and process mapping skills
• Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals
• Effectively work within a team environment and interface with peers, management, etc.
• Strong commuter skills, including experience working wth SAP Planning/Master Data management, project management software and Microsoft Word, Excel, PowerPoint and Visio
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Process Validation Contractor
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Duration: Contract
Location: Las Piedras,PR
DESCRIPTION
· The Process Validation Contractor will be responsible for designing validation processes and supporting product/process remediation activities related to product commercialization and technology transfer of products.
- Focus of this role includes cross functional alignment on technical and validation deliverables with key stakeholders including Operations, Quality, Project Management and R&D.
- The Process Validation Contractor is recognized as subject matter expert with respect to formulation development, process development, process transfer, and process validation. This includes only solid dosage forms but may include packaging, cGMP systems and requirements.
- In this capacity, the Process Validation Contractor will design processes for validation, product/process transfers and continued process verification; including data analysis, gap analysis, identification of critical technical and compliance requirements, technical and compliance documentation review, and process metrics. The primary function of this role is the development and implementation of enhanced validation processes and procedures
- The Process Validation Contractor will provide technical input for strategic company guidelines and policies. This individual will partner both intra and interdepartmentally
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Product Release Team Leader
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Duration: 36 months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
The Product Release Team Leader will be responsible for managing all release activities in Companies facility in Lancaster, PA.
• This successful candidate is responsible for ensuring the complete review and approval of those products manufactured and/or packaged at the Lancaster (LN) facility.
Primary responsibilities include the review of all laboratory and manufacturing information to support disposition of a batch prior to release.
• This includes performing a holistic product family review of retrospective data, interpretation of laboratory and manufacturing events, review and agreement of all quality notifications, identification/verification of trends, preparation of weekly management summary reports and interface with the site planning group for batch release prioritization.
• This individual may also provide support for the other elements of the Lancaster Quality Assurance group (Quality Notification review, batch record release, manage meetings associated with batch release) as needed.
• This individual may also be required to participate in cross functional teams providing compliance support as needed.
• A minimum of 5 years of related work experience in a pharmaceutical and/or biological manufacturing operation focused on Quality Assurance and Product Release. Experience in a Pharmaceutical/OTC drug production environment is required
• The ability to analyze data using statistical tools is required.
• A minimum of 4 years of general business experience is required.
• A minimum of 5-8 years of experience in a GMP regulated industry is preferred.
• Technical writing experience is required.
• Experience writing and putting together Annual Product Review summaries is required.
• GMP Manufacturing Process/Laboratory Experience preferred.
• Understanding of New Drug Development process, Technical Transfer and Process Validation preferred.
• Knowledge of cGMP requirements and current FDA enforcement issues are required.
• Proficiency with Microsoft Office is required.
• Keen attention to detail required.
• Demonstrated ability to maintain positive working relationships with others.
• Expertise in handling multiple priorities preferred.
• Investigation skills with Non-Conformances and/or CAPAs preferred.
• Knowledge of SAP is preferred.
• Experience with LIMS and EtQ is preferred.
• A BS or BA degree in a technical discipline such as chemistry, biology, microbiology, virology, engineering or pharmacy.
• A focused degree in a scientific/technical field is required
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Project Lead(LIMS)
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Duration: 4 months
Location: Swiftwater,PA
DUTIES >> This resource will provide project leadership and support services to Companyby
- leading matrixed teams consisting of IS and business team members and
- performing / leading specified project activities and
- developing project deliverables.
These services will be in support of the LabWare LIMS Instrument Interfacing project, QC Lab Scheduling project and other projects as assigned.
The Project Leader Consultant will be focused on project management activities and responsibilities which include the following:
- Local project leadership of LabWare LIMS Instrument interfacing and related master data updates in Swiftwater
- Local project leadership of LabWare LIMS Business Change Requests (system enhancement requests)
- Local project leadership for QC Lab Scheduling project
- Local project leadership for other IS IO Quality projects as assigned
DELIVERABLES
- Develop various project documents such as plans, protocols, scripts and other project documents as directed
- Lead project meetings, develop presentations and document project activities as per CompanyPUMA project methodology
- Create and maintain project plans
- Provide weekly and monthly status reporting on assigned projects as directed
- Other duties as assigned
GENERAL EXPECTATIONS
- Documentation will be consistent with CompanyIS standards as provided
- Service provider will meet with Manager weekly to review deliverables of previous week, confirm expectations for current week, and address any concerns. Projet Leader consultant will provide a status report for the review meeting.
- Deliverables as per agreed upon work plan will be tracked.
SKILLS >> An experienced project manager with demonstrated skills in leading IS projects in FDA-regulated environments, preferably in quality control laboratories or related GMP areas. Experience leading implementations of LabWare or other commercial LIMS implementations in FDA-regulated environment preferred. Project manager must be skilled in leading matrix teams consisting of both IS and business teams members and motivating the team to achieve project timelines. Experienced in developing and maintaining project plans, presentations, working with business stake holders, status reporting required. Able to author plan level documents as well as protocols, specifications and test scripts as required to complete documentation necessary for validated computerized systems. Must be capable of working independently to lead projects, motivate teams and be resourceful in finding innovative solutions for resolving project barriers while ensuring compliance with Companymeth!
odologies and procedures.
EDUCATION >> - BS/BA in Information Technology or Biological Sciences
- Project management certificate and / or PMP Certification
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Project Manager
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Duration: 12 months +
Location: Lancaster,PA
PM for remediation of legacy systems for Computer Systems Validation.
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Project Manager / Project Coordinator
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Duration: 5 months
Location: Swiftwater,PA
Duties: The scope of this position is to provide management and/or coordination services for the implementation of a Manufacturing Execution System (MES) using Siemens XFP software.
The system will interface to our document management systems and our Enterprise Resource Planning system SAP.
This individual will be responsible for supporting the IS Project Leader to ensure the project is delivered on time, on budget and to the intended scope as defined by the project teams.
The individual will be responsible for resource management, development and maintenance of project plans, day to day management of activities, change management, coordinated reporting and presentation of project status, resource allocation and other project-related information to IS and Business management.
The project is currently in the execution stage so, emphasis on team effectiveness and results will be needed.
Skills: 5+ years project management experience working on IT projects. PMI certification is preferred.
Experience with implementation of Manufacturing Execution Systems is desired, preferrably within the pharma industry.
Some experience with agile project management techniques is also desired.
Office Tools
Word
PowerPoint
Excel
Visio
MS Project
Experience working with FDA regulated industries
GAMP validation strategies is highly desired
Excellent written and verbal communication skills
Education: Degree
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QC Analytical Manager
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Duration: 36 Months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
• Manages the QC Analytical Laboratory staff for all testing conducted at the Lancaster facility.
• These functions include the testing of: chemical components, bulk and finished products, packaging materials, scale-up samples, process validation samples, cleaning validation samples, marketed stability samples, development samples, and investigational samples.
• Review and approval of: SOPs, testing protocols, component specifications, method specifications, and method qualifications protocols.
• Provide and/or manages cGMP and safety training to the QC Staff.
• Provide information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries.
• Develop and implement procedural guidelines within the Quality Control department in conjunction with Central Quality Assurance and other plant sites. Represents the department internally and externally in matters relating to Analytical Laboratory, cGMPs and general quality. Responsible for hiring, firing, disciplining and rewarding of employees.
• Five to ten years of QC/R&D Analytical Laboratory experience in a pharmaceutical industry environment. A minimum of 3 years of supervisory experience. Experience in the application of cGMPs in the pharmaceutical industry.
• Basic knowledge of Pharmaceutical Manufacturing & cGMPs.
• Basic knowledge of QC Analytical.
• Basic knowledge of Statistics and Quality Engineering principles.
• Ability to administer team building strategies.
• Demonstrates good interpersonal skills.
• BS in Chemistry or other Physical or Natural Science or equivalent combination of education and experience.
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QC Micro Manager
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Duration: 36 Months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
• Manages the QC Microbiology and R&D Microbiology testing laboratory for the Lancaster facility.
• These functions include the microbiological testing of: chemical components, bulk and finished products, packaging materials, scale-up samples, process validation samples, cleaning validation samples, marketed stability samples, development samples, and investigational samples.
• Review and approval of: SOPs, testing protocols and method qualifications protocols.
• Provide and/or manages cGMP and safety training to the QC Micro staff.
• Provide information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries.
• Develop and implement procedural guidelines within the Quality Control Microbiology laboratory in conjunction with Central Quality Assurance and other plant sites.
• Represents the department internally and externally in matters relating to the Microbiology Laboratory, cGMPs and general quality.
• Responsible for hiring, firing, disciplining and rewarding of employees.
• Basic knowledge of Pharmaceutical Manufacturing & cGMPs
• Basic knowledge of Microbiological techniques and applications
• Basic knowledge of Statistics and Quality Engineering principles
• Ability to administer team building strategies
• Demonstrates good interpersonal skills
• Five to ten years of QC/R&D Microbiology Laboratory experience in a pharmaceutical industry environment.
• A minimum of 3 years of supervisory experience. Experience in the application of cGMPs in the pharmaceutical industry.
• BS in Microbiology, Biology, Chemistry, Natural Sciences or equivalent combination of education and experience.
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Quality Assurance Manager Consultant
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Duration: 6 Months
Location: Fort Washington,PA
DESCRIPTION AND QUALIFICATIONS
• Coordinate all tech transfer QA deliverables across multiple project teams, quality account managers, and external sites
• Develop, track and trend External Manufacturer planned due dates, and report on execution according to plan
• Assist in prioritizing work across commercial project managers and quality account managers
• Represent quality account managers on project teams and ensure communication of necessary deliverables
• 10+ years of experience in leading, managing complex multi-functional, multi-disciplined projects. Experience in pharma industry required.
• Project Management certification desired/preferred. Experience in project management in a compliance discipline.
• BS in a Technical Field
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Quality Assurance Team Leader Consultants
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Duration: 36 Months
Location: Lancaster PA
Two Openings
DESCRIPTION AND QUALIFICATIONS
• The position provides daily direction, planning and compliance focus to the Process Review Team consistent with the supply chain’s goals, while meeting the compliance goals of Quality Assurance. Provides compliance perspective and expertise to ensure that the process consistently meets all internal and Regulatory Quality standards. Measures, tracks, trends and promotes improvement of process metrics. Facilitates resolution of issues to improve site metrics. Provides training and direction as needed to direct reports and guidance on setting objectives, frequent feedback and timely performance reviews to direct reports.
• 3-5years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement
• Active cGMP Interpretation and Application Experience
• Demonstrated leadership- possesses the ability to lead a team
• Strong Organizational Skills
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Managerial Courage
• Problem Solving/Investigation Experience
• Expertise in Handling Multiple Priorities
• Technical B.S. or B.A. College Degree preferably in a Science
• 4 years professional experience in a regulated industry
• Supervisory Experience
• Project Management Experience preferred
• Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation
• Validation Experience preferred
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Quality Risk Management Consultants
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Duration: 24 Months
Location: Philadelphia Area
Healthcare company in the Philadelphia area is in need of 2 Quality Risk Management Managers for 24 month assignments for a Pharmaceutical Manufacturing GMP Certification Readiness. The Consultant must have 5 years of experience in a Quality and or Compliance roles in the Pharmaceutical Industry.
DESCRIPTION and RESPONSIBILITIES
• The Quality Risk Management (QRM) Manager is accountable for developing a Quality Risk Management program based on the principles contained in ICH Q9 and compatible with Quality systems required by current Good Manufacturing Practice (GMP), corporate standards, and regulatory expectations.
• The QRM Manager will develop a training module and training curricula suitable to the appropriate function and role requiring training.
• The QRM Manager will deploy the training and lead the training across the Company network.
• The QRM Manager will be responsible for establishing and tracking metrics associated with the roll-out and implementation of the QRM program.
ROLES and RESPONSIBILITIES
• The QA Manager supports multiple functions, exercises sound and timely decision making by utilizing Quality Risk Management principles, statistical and problem solving tools.
• Establish and track associated metrics, identify opportunities for improvement and develop appropriate action plans.
• Lead or manage, as appropriate, Consent Decree-related workplan activities associated with the above while interacting with internal and external entities to harmonize practices and standards across the US OTC.
QUALIFICATIONS
• A minimum of a Bachelors degree is required. A degree in chemistry, microbiology, or science discipline is preferred.
• A minimum of 8 years of experience in the pharmaceutical industry. A minimum of 5 years in a Quality and/or Compliance management role is required. Position may require a minimum of 25% travel.
• A critical understanding of Drug cGMP's and the systems used to deploy them is required. Previous experience deploying ICH Q9 is preferred. Previous experience utilizing risk management tools, including Six Sigma, Black Belt, FMECA, HAACP, etc. highly desirable
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Senior Compliance Internal Auditor
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Duration: 36 Months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
• Responsible for all activities related to the execution of the Internal cGMP Audit program for the Plant.
• Assist in the development of the annual internal audit plan.
• When required, coordinate with other trained plant personnel to perform overflow audits.
• Minimum 5 years Pharmaceutical Operations and/or Quality Experience.
• Requires a professional and ethical approach to all activities and dealings. Must demonstrate leadership through example, with confidence to accept responsibility and accountability for making decisions.
• Must demonstrate firm conviction on regulatory boundaries, in the face of challenges and pressures.
• Strong communication and organizational skills.
• Knowledge, Skills and Abilities:
o GMP Auditing Experience
o Experience working with MS Office software applications
• Certifications/Licenses: ASQC Certified Quality Auditor is a plus, but not required
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Validation Compliance Specialist
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Duration: 36 Months
Location: Lancaster,PA
DESCRIPTION AND QUALIFICATIONS
• The individual will have overall responsibility for the regulatory compliance of all validation activities within the Lancaster, PA plant. Additionally, the individual will partner with validation resources at other sites to ensure harmonization, appropriate trouble shooting and leverage of best practices.
• The individual will be expected to lead and manage the validation program while simultaneously balancing business, technical and quality issues and enhancing the site master validation plan.
• As required, the individual will provide support to change control functions by reviewing and approving change controls related to validation.
• 8-10+ years experience in a GMP-related industry.
• Experience in writing and executing validation documents.
• Working knowledge of change control activities.
• Excellent working knowledge of cGMPs
• Strong technical, interpersonal, communication and facilitation skills.
• Good understanding of engineering, computer and pharmaceutical manufacturing systems.
• Flexibility to accommodate some very limited travel.
• Knowledgeable of cGMPs and industry standards for equipment, process, packaging and cleaning validations.
• Excellent oral and written communication skills.
• Bachelor’s degree in Biology, Chemistry, Microbiology, Engineering or related technical degree.
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Validation Compliance Specialist -B
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Duration: 36 Months
Location: Lancaster PA
DESCRIPTION
• Review cleaning, packaging, process, system/equipment, facility/utility qualifications, validation documentation, drawings, change controls and standard operating procedures.
• Team with subject matter experts in Engineering, Laboratories, Operations, Quality, R&D for compliance review of validation documentation against SOPs, industry standards and best practices
• Assist with protocol/report inventory and current status of validation
• Comply with applicable regulatory, safety and environmental guidelines.
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Validation Lead
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Duration: Contract
Location: Fort Washington,PA
This is a role to lead the Companies Consent Decree (CD) Strategy and execution at the FW Plant for the Validation related Quality Standard Elements QSE 6 “Validation” , QSE 7 “Product Development” and QSE 9 “Facility, Utility and Equipment . This leader will be focused as point of reference and go to person for the FW Plant CD related requirements in regards to the implementation of the QSE 6, QSE7 and QSE 9 requirements and related Certification readiness requirements. This position will lead the integration of FW Plant Re start Operations Readiness team with the CD work plan work streams leaders. This leader will seek resolution of constraints and representing and reporting to the Consent Decree Management Office (CDMO) for the FW Plant on CD matters and metrics related to FW Plant QSE 6, QSE 7and QSE 9.
This position will report to the FW CD Site Leader and will be a member of the FW Re Start team Operation Readiness. This leader will work closely with the Operations Re start Project Director to assure all CD activities are executed in alignment with the overall Companies CD requirements and FW Plant Re start requirements. The incumbent will manage complex integration issues, interfacing with senior management on a regular basis and change management CD related issues.
PRINCIPAL RESPONSIBILITIES:
• Coordinates and leads CD requirements and certification requirements
• CD guardian and advocate
• Fully dedicated to CD execution: contact person within business for planning & coordination on CD matters
• Assure execution of CD work plan: assures implementation of critical projects that support CD commitments
• Monitor and report on progress of CD work plan: leads design of Home Office Site metrics that help drive CD execution
• CD communicator to management
• Integrator of CD teams
• Partners with business leaders to enable resolution of constraints between CD and other business work streams (base business, regulatory inspections, etc)
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Validation UAT Test Script Writer
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Duration: 2 1/2 Months
Location: Bridgewater,NJ
Write User Acceptance test scripts -including some required knowledge of Documentum/FirstDoc & SharePoint is required. Dry run execution of test scripts. Manage UAT test script inventory under direction of Test Director (version control of test scripts, distribution of scripts to target testers, execution status, re-execution, anomaly tracking, harvesting completing test scripts. Support anomaly reporting and resolution
SKILLS >> Hands-on validation experience using Documentum,FirstDoc & SharePoint in a large regulated environment with Workflows, Watermarking, Rendering, and ACLs. Hands-on experience with compliance layers such as FirstDoc a plus.
EDUCATION >> Hands-on validation experience using Documentum,FirstDoc & SharePoint in a large regulated environment with Workflows, Watermarking, Rendering, and ACLs. Hands-on experience with compliance layers such as FirstDoc a plus
