QA Specialist

2/10/22

Princeton, NJ

1588

QA Specialist

Overview:

To review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures with minimal supervision. To release products, drug product components and container-closures. To review and write cGMP procedures under supervision. To report periodic quality metrics.

Responsibilities:

  • Review manufacturing batch records, testing results and deviation reports
  • Interact with other departments to address review observations
  • Release drug product, drug product components and container-closures
  • Interact with customers on batch record reviews and batch releases
  • Attend department meetings on batch record review and releases
  • Maintain and report quality metrics on batch record review and releases
  • Review and write standard operating procedures
  • Review quality system documents (change controls, validation, complaints)
  • Review master batch records and maintain records
  • Process, investigate and follow-up on product complaints
  • Perform other tasks as requested by management.

Qualifications:

  • Bachelor’s Degree (BA or BS), preferably in a Natural Science, is required
  • A minimum of 3 years of relevant experience in the pharmaceutical industry is required.

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