Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Pennsville, USA
Posting date: 12 Oct 2023

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.