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