Quality Assurance Specialist job in Pennsville, USA

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Job type: Permanent

Discipline: Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

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

Proclinical is seeking a Quality Assurance Specialist for a leading pharmaceutical company located in Pennsville, NJ.

Must be eligible to work in the US.

Job Responsibilities:

Reviews and approves executed production records, production investigations, Master Production Records, COAs and DMFs
Reviews lab sample results and manufacturing records relative to qualification/validation activities.
Conducts, writes, and reviews quality related investigations
Responsible for cGMP compliance of assigned manufacturing operations / areas and conducts cGMP inspections
Completes pre-campaign action items as assigned.
Responsible for the conditional / final release of materials
Reviews finished product labels.
Prepares and reviews product trees
Writes and reviews Product Validation / Qualification / Assessments documents, Equipment Qualifications / Assessments documents and
Computerized Systems Validations / Assessments documents
Reviews, evaluate and approves minor equipment changes
Conducts environmental monitoring

Skills and Requirements:

BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.BA/BS degree in microbiology is preferred
Thorough knowledge of cGMP is required
Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Code of Conduct
Adheres to all applicable SHE and CGMP regulations
Must have excellent communication skills
Must be conscientious and detail-oriented
Must have excellent computer skills (MS Office, WinLIMS, SAP)
Must be a team player
Must be able to self-manage daily work and set priorities
Must be able to manage projects and prioritize appropriately

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at +(1) 857-233-9215 or c.chung@proclinical.com.

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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