Job Board

The Document Control Specialist is responsible for tactical activities related to all aspects of document control (creation, revision, approval, distribution, obsolescence and retention) providing daily support to the Lancaster Site consistent with the supply chains’ goals while meeting the compliance goals of QA.

Primary Responsibilities:
• Becomes proficient in the EDM System as an administrator
• Assures that the routine review of SOPs occurs as required
• As necessary, updates site or related Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Assures that the site remains compliant with all aspects of the applicable Company Quality System Standard(s)
• In conjunction with site management, assures that training is considered for SOPs, MBR, etc. when written.
• Assures that the administration of the EDM System and the Manual Document System maintains documentation control as per company requirements.
• Performs all required activities of the Document Control Specialist(s) including document creation, revision, approval, distribution, obsolescence, retention activities and batch record issuance activities.


Experience in document control/management in a regulated environment preferred. Knowledge/experience with implementation and maintenance of an Electronic Document Management System, particularly EDM or Documentum.

Responsibilities:

The ideal candidate will need to understand Electronic Document Management System workflows including CSV methodologies.  Resource is needed to supplement IT CSV validation review workload including plans, specifications, designs, protocols, test scripts, reports and operational procedures.

Candidate qualifications:

·         Knowledge of SDLC

·         Knowledge of Electronic Document Management System (Specifically Documentum)

·         SME Review and approval of CSV validation documentation

·         Provide advice, guidance, coaching and mentoring to client for proper validation of computer systems

·         Expert knowledge of GMP, 21 CFR part 11, 21 CFR Parts 210, 211

·         Good documentation practices

·         Long-term experience in pharmaceutical manufacturing in technical or QA capacity

·         Regular and effective communication of project status to Project Management.

 

 

Experience with Electronic Document Management Systems preferred but candidate should be well-rounded enough to be able to transfer over to other CSV validation efforts at conclusion of project.

A. Required Education/Training and/or Experience:
2 years of experience in the Pharmaceutical industry, with experience working with packaging test methods and equipment preferred.
B. Required Skills/Abilities:
Experience in writing technical documentation is required. Broad knowledge and experience with packaging test methods (e.g. ASTM, ISTA etc.) is preferred. Experience working in a GMP regulated environment including knowledge of GMP’s GLP’s, and SOPs, is required. Effective communication skills with all levels, time management skills and strong computer skills are required.

Experience working in a cross functional, fast-paced environment is required. A highly motivated individual with strong technical, analytical and interpersonal skills and the ability to partner effectively across functions and levels is required. There may be a requirement to travel to manufacturing sites or distribution centers. Travel is estimated to be <10%.

Education:
A minimum of a B.S. degree in Package Engineering or related Engineering/Technical discipline (i.e. Mechanical, Materials Science, etc.)

The Packaging Validation Specialist will oversee end-to-end packaging validation activities and be responsible for reviewing packaging equipment qualification and validation documents. This role is the lead for validation execution and support for development and qualification activities at contract packaging sites including the tranisiton to new Validation SOPs. The focus of this role includes facilitating cross-functional alignment on validation requirements and deliverables with contract packaging sites and key stakeholders including Operations, Quality, Project Management, Site Engineering and third party auditors.

A minimum of 7 years experience in packaging validation for FDA regulated products.
• Demonstrated interpersonal and written communication skills.
• Demonstrated problem-solving and troubleshooting skills.

The Packaging Equipment Validation Specialist is recognized as subject matter expert with respect to validation requirements for solid and liquid dosage packaging wiht prior hands on experience with OTC and/or Pharmaceutical packaging processes.

In this capacity, the Senior Packaging Equipment Validation Specialist will review and audit past qualification activities in support of future validations. The candidate will require flexibility reviewing processes and multiple source documents in an effort to identify critical technical and compliance requirements. The primary function of this role is the development and implementation of enhanced packaging validation processes and procedures. The Packaging Equipment Validation Specialist will provide technical input for strategic company guidelines and policies. This individual will partner both intra and interdepartmentally. In addition, the Senior Packaging Equipment Validation Specialist will be responsible for:
. Audit / review of existing Qualification documentation (IQ/OQ)
2. Confirmation of packaging equipment information to support development activities
3. Communication of Company Validation requirements
4. Assessment of current documents against new standards
5. Reviewing PQ and PPQ protocols
6. Reviewing PQ and PPQ final reports

The Packaging Validation Specialist II will be responsible for supporting packaging line validation remediation activities. The focus of this role includes remediation of solid dosage bottling and blistering packaging line validations.

The Packaging Validation Specialist II will be responsible for authoring through execution of packaging validation remediation activites including, but not limited to:
1. Authoring Remediation Plans
2. Authoring & Executing Packaging Performance Qualifications and Process Performance Qualifications
3. Executing quality documents review in support of packaging performance monitoring program.

• A minimum of a Bachelors of Science degree in Engineering or Technical discipline with a minimum of 3 years experience in equipment qualifications and validations for FDA regulated products.

Looking for someone who knows Red Prairie or any related WMS systems, Quality Center (HPQC), Solution Manager (SolMan), and Change Control within SolMan.