Manufacturing Specialist

3 days ago


Philadelphia, Pennsylvania, United States Planet Pharma Full time
Job Title: Manufacturing Specialist - Document Control

Planet Pharma is seeking a highly skilled Manufacturing Specialist to support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.

Key Responsibilities:
  • Lead teams investigating minor, major, and critical non-conformances and deviations, including gathering information through structured root cause analysis.
  • Own and manage change controls associated with manufacturing areas and equipment.
  • Participate in technology transfer, conference calls, and sharing of technical information.
  • Coordinate front-end document requests with supporting departments.
  • Ensure 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.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
  • Complete recording of data to comply with regulatory requirements.
  • Attend weekly management meetings to discuss timelines and weekly priorities.
  • Contribute to projects to ensure timely initiation and completion of work.
  • 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.
  • 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 Planet Pharma's 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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