Senior Quality Assurance Specialist

3 weeks ago


Reston, Virginia, United States Astrix Full time

At Astrix, we are seeking a highly skilled Senior Quality Assurance Specialist to lead our Quality Control team in the pharmaceutical industry.

Type: Contract-to-hire

Pay: Up to $37/hr

Location: Middlesex County, NJ

Duties:

  • Ensure compliance with cGMP regulations and industry standards in a GMP-compliant environment.
  • Develop and manage schedules for QC analysts to optimize testing activities.
  • Author, review, and revise technical documents, including protocols, specifications, reports, SOPs, test methods, and impact assessments.
  • Conduct laboratory investigations, including experiments, and write thorough investigation reports with scientific justification and root cause analysis.
  • Review/perform equipment calibration, validation, and maintenance records to ensure timely and accurate completion.
  • Optimize, validate, and manage the transfer of cell-based assays from R&D or external labs to the QC lab.
  • Operate testing instruments, including HPLC, GC, UV, ICP-MS, FTIR, TOC, CE, ICE, Karl Fisher, VHP Isolator, Plate Reader, etc., during testing.
  • Perform laboratory techniques, including qPCR, ELISAs, and other relevant methods.
  • Assist in the creation, review, and closure of Change Control records.
  • Conduct quality testing, review QC data, and prepare Certificates of Analysis.
  • Maintain and review quality records.
  • Train and assist junior QC team members, manage, coach, and mentor direct reports to ensure completion of training curricula.
  • Monitor and maintain quality metrics for stability testing.
  • Apply problem-solving and statistical analysis tools to drive root cause identification and process improvement.
  • Initiate and investigate OOS, OOT, and lab incidents.

Qualifications:

  • Bachelor's degree with 5+ years of experience in QC or related roles in the pharmaceutical/biopharmaceutical industry.
  • M.S. with 2+ years of industry experience in QC or equivalent roles.
  • Comprehensive knowledge of cGMP in pharmaceutical/biopharmaceutical settings.
  • Experience in inspection readiness for audits.


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