Quality Assurance Specialist
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Proclinical is seeking a Quality Assurance Specialist for a leading pharmaceutical company located in Pennsville, NJ.
Must be eligible to work in the US.
- 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 email@example.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.