Quality Assurance Associate
Enco Pharmaceutical Development, Inc.
Cary , NC 27511
Posted 3 weeks ago
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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.
- 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.
Full Health, Dental, Vision, 401K