QA Specialist

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.

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