Senior Associate, Quality Compliance - Princeton

Only for registered members Princeton, United States

1 month ago

Default job background
$90,000 - $112,500 (USD)

Job summary

The Quality Assurance Specialist is responsible for the batch certification review of site QA activities related to manufacturing and packaging records, as well as all supporting documentation. This includes ensuring compliance with Standard Operating Procedures (SOPs), equipment and instrument maintenance, calibration, qualification, and validation in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA++ principles.

Responsibilities

  • Support batch certification activities for commercial distribution in the USA and Canada.
  • Serve as a subject matter expert in sterile manufacturing and packaging processes.
  • Review investigations related to site incidents and deviations.

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