Quality Assurance Associate

Enco Pharmaceutical Development, Inc. Cary , NC 27511

Posted 3 weeks ago

ENCO Pharmaceutical Development, Inc. is seeking an experienced candidate for the position of Quality Assurance Associate in our Cary, NC facility. The successful candidate will be a team player, have a strong understanding of basic chemistry, detail-oriented, and work well in a cGMP environment. Strong organizational skills and the ability to manage multiple deadlines as well as knowledge of appropriate regulatory requirements are essential to success.



Position Summary:
  • The Quality Assurance Associate is responsible for the support and implementation of the QA program designed to meet client data quality objectives and regulatory compliance.
  • Additional responsibilities include:
    • Data Review.
    • Performing various tasks in support of the administration and maintenance of Quality System Components (i.e. Calibration Control, Document Control, Records Management, Logbook Issuance, Auditing Functions, etc.).
    • Monitoring and assessing compliance with requirements contained in the QA program
    • Conducting audits and inspections to assess compliance with established methods, policies and procedures.
    • Participate by investigating out-of-specification results and non-conformances as required.
    • Maintaining regulatory compliance programs.

Requirements

  • Knowledge of appropriate FDA regulatory requirements and cGMPs
  • Detail Oriented
  • Good communication skills, oral and written
  • Works well with others
  • Knowledgeable user of Microsoft Word/Excel.

Benefits

Full Health, Dental, Vision, 401K

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Quality Assurance Associate

Enco Pharmaceutical Development, Inc.