Sr. QA Specialist


  • Manufacturing operations
  • Microbiology
  • EEO
  • Collaboration
  • Quality assurance
  • Training
  • Business analytics
  • Biology
  • Business analysis

Job Description

Job#: 1347390

Job Description:

Apex is seeking an experience Quality Assurance Specialist to join a growing Pharmaceutical company in the Southern New Jersey area.

IT and Software QA experience will not be considered.

  • 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
  • Maintains QA databases for products / equipment

Education and Experience:
  • BA/BS degree in Microbiology (preferred), Biology, Chemistry, or Engineering.
  • 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required.
  • Thorough knowledge of cGMP is required

Only local candidates will be considered.

IT and Software QA experience will not be considered.

For immediate consideration, please apply or email a copy of your resume to David Neto.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.