Quality control analyst / investigator

DUTIES: Support day-to-day quality control activities within a GMP manufacturing environment and multiple quality control laboratories that test in process and final drug product, with testing dedicated to cell and gene therapy. Perform deviation investigations for all areas of Quality Control within MasterControl, incl. out of specification events with an emphasis on analytical assays (flow cytometry, ELSA, and other cell-based assays) and microbiological assays. Investigate out of trend events and atypical results. Use root cause analysis tools to determine root cause and put processes in place to reduce reoccurrence. Work cross-functionally with QC, Manufacturing, Sterility Assurance, Quality Assurance, Facilities and Supply Chain to create relevant CAPAs. Support the maintenance of databases for QC metrics and KPIs. Revise quality documents to support deviation mitigations and CAPAs. Support programs related to deviation reduction and on-time closure rates for all quality records. Prepare and organize release documentation, ensure GDP, maintain high level of quality on site, author/review CoAs and CoTs for product release, and comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations + perform other duties, as required.

May be assigned to various, unanticipated sites throughout the United States.

REQUIRED: Education : At least a bachelor's degree in biology or life sciences field. Experience: At least 2 years in position offered or in the biopharmaceutical industry within a CGMP Quality Control role. Skills: cGMP Quality Control; 21 Code of Federal Regulation Part 11; update and review existing SOPs for QC testing; investigate deviation, out-of-specification and out-of-trend event; perform technical writing of deviation reports; data review for lab reports involved in investigations; preparation of regulatory audits; develop CAPAs. Hiring Requirements: Background Checks + Drug Testing/Screening

SALARY RANGE: $115,000 to $138,000 per year

BENEFITS: Medical/dental/vision/income protection plans; HSA; paid time off & parental leave; EAP; wellness programs; legal & identity theft insurance; 401(k); stock purchase plan; professional development; annual cash bonuses & long-term incentives

To apply, email resume to [email protected] and include "Quality Control Analyst/Investigator (CAPA/Lab Support) role" in the subject line.