QA Specialist job in Frederick, USA

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Last Name*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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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