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GMP / Quality Lead

Trenton Metro Area, NJ

Posted: 07/17/2018 Job Type: Scientific Job Number: JN -072018-22065
GMP / QA Auditor
Provide leadership for continuous improvement in all aspects of GMP Quality. This includes the development and administration of policies and practices which address quality issues throughout the organization.
  • Direct and conduct GMP based Quality audits, and associated CAPA.
  • Ensure vendor oversight as well as inspection readiness.
  • Serves as representative in manufacturing based audits with the FDA and other government agencies.
  • Provide guidance and direction regarding manufacturing Quality to project teams. This includes, but is not limited to, documentation, training, change control, investigations, deviations and record review.
  • Provide expert knowledge regarding data integrity program including computer system validation practices, as appropriate.
  • Develop and execute training programs regarding cGMP, quality management techniques, etc.
  • Act as subject matter expert regarding SOPs for GMP Quality functions
  • Education and Experience
  • Bachelor s degree in a scientific/technical discipline.
  • Advanced degree in biotechnology, microbiology, biochemistry preferred.
  • Minimum of 10 years of directly relevant pharmaceutical industry experience
  • At least 5 years working with biopharmaceuticals, preferably monoclonal antibodies.

  • Technical Skills
  • Subject Matter Expert on current standards for quality assurance of sterile biologic medicinal products including: aseptic processing, sterility assurance, equipment and process validation, quality control, environmental monitoring, and facility management.
  • Strong knowledge of cGMPs as well as other relevant regulatory requirements and experience in interacting with the Health Authorities in GMP inspections

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