Quality Assurance Specialist

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.

#LI-CC1

INDCQA