Manufacturing Specialist- Document Control
1 month ago
615374
Our client, a leading Pharmaceutical company in Philadelphia PA, is looking for a Manufacturing Specialist to support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
Required Skills:
- Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
- Cell culture experience
- Strong experience in quality record/document ownership; deviations, CAPAs, change controls etc.
Responsibilities:
- Lead teams investigating minor, major and critical non-conformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
- Own and manage change controls associated with manufacturing areas and equipment.
- Participate in technology transfer, conference calls and sharing of technical information.
- Coordination of front-end document requests with supporting departments.
- Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
- Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Attends the weekly management meeting to discuss timelines and weekly priorities.
- Contribute to projects to ensure timely initiation and completion of work.
- May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
- Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.
- Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
***Compensation within this range will be commensurate with level of experience***
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