Sr. Quality Control Specialist

2 weeks ago


Philadelphia, United States Planet Pharma Full time

606454


Our client, a leading Pharmaceutical company in Philadelphia, PA, is looking for a Sr. Quality Control Specialist to be responsible for the review of the executed test methods and raw data for lot release


Required Skills:

  • Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
  • Minimum 5 years of experience in the biopharmaceutical industry within a Quality Control role
  • Must have experience with OOS investigations, deviations, change controls and CAPAs.
  • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
  • Solid understanding and functional knowledge with hands-on experience with Cell base Assays, cell culture (primary cells and cell lines),
  • Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)


Responsibilities:

  • Performs review and approval of CMO/CTL OOS investigations, deviations and other quality events.
  • Performs review and approval of CMO/CTL change controls.
  • Performs data analysis of CMO release testing to support product lot release with adherence to turnaround times.
  • Issue and write change controls and CAPAs when required.
  • Analyze and interpret technical laboratory data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the laboratory operations environment.
  • Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate documents.
  • Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed.
  • All duties are performed with minimal supervision and oversight.
  • Performs other duties as assigned.



***Compensation within this range will be commensurate with level of experience***



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