QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)
  3. United States
Frederick, USA
Posting date: 03 Dec 2020

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Frederick, MD.

Job Responsibilities:

  • Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
  • Coordinate and facilitate Quality Assurance related production and production related activities, including:
    • Issuance of electronic batch records and manufacturing labels.
    • Assessment and closure of discrepancies, deviations and change controls requests.
    • Assessment and closure of laboratory investigations.
    • Timely assessment and closure of batch and material hold events.
    • Communicate lot disposition pending issues to management.
    • Review of batch manufacturing and testing documentation for timely delivery of final product.
  • Ensure that tests are performed and products are manufactured in compliance with company specifications, regulatory and GMP guidelines.
  • Ensure that tests are performed and products are manufactured in compliance with company specifications, regulatory and GMP guidelines.
  • Support development of SOPs and review/approve SOPs to ensure quality objectives are met
  • Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
  • Review and approve manufacturing production records.
  • Compile and verify all batch related documents into a final product lot disposition package.
  • Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
  • Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
  • Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.
  • Review and disposition raw materials, components, and labels for GMP use.
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
  • Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

Skills and Requirements:

  • 4+ years of QA experience with the pharmaceutical/biotech industry
  • Experience with CAPAs, deviations, investigations, and OOS/root cause analysis
  • Writing SOPs
  • Strong knowledge of GMPs/cGMPs

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.