Quality Control Data Reviewer

Philadelphia, PA

The Fountain Group is currently seeking a Quality Control Data Reviewer for a prominent client of ours. This position is located in Philadelphia, PA. Details for the position are as follows:
  • Pay: $34-44.82/hr.
  • 12-month assignment with possibility for extension or conversion based on performance and budget.
Responsibilities:
  • Review and approve GMP data, including paper and electronic data
  • Review audit trails and instrument logbooks
  • Hire, train, and supervise data reviewers
  • Develop and maintain data integrity program
  • Author and review SOPs, manage non-conformance events as needed
  • Develop and maintain department metrics on turnaround and right first time Supporting QC during audits and regulatory inspections
Qualifications:
  • BS or MS degree on biological, chemical sciences, or related discipline, is required.
  • 5+ years for BS, 2+ years for MS, 1+years for PhD, of related experience in the
  • Pharmaceutical/Biotech industry working in a GMP/regulated environment.
  • Strong scientific knowledge and demonstrated analytical background are required.
  • Should be familiar with the following assays: SDS-PAGE, Western Blot, SEC, CE-SDS, cell-based assay, qPCR, ddPCR, ELISAs, DLS, compendial assays.
  • Excellent understanding to data integrity principle is required.
  • Proven experience in analytical instrument is preferred.
  • Experience in reviewing audit trail is preferred.
  • Experience in lab investigation and deviation is preferred.
  • Excellent communication skill is required
If you are interested in hearing more about the position, please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
 
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