Quality Assurance Associate I

Reports to: Quality Assurance Supervisor or Manager

Responsibilities:

• Conducts Annual Drug (Product) Reviews and Device History Reviews.

• Maintains Regulatory Compliance documents and documents of external origin.
• Maintain Document Control (including Records Retention)
• Participates in internal and external audit process.
• Participates in Mock (product) recall audits.
• Maintain SOPs and Quality Forms as part of Document Control.
• Maintains records of customer-approvals documents as evidence of authenticity.
• Participate in QA Audits and draft reports of such audits.
• Effects changes to specification sheets as approved through change control requests.
• Support Change Control program and maintain evidence of product and process changes.
• Maintains SOP binders and updates such documents through approved CCs.
• Supports EWL Employee...

Navarro Research and Engineering is recruiting for a Quality Assurance Associate Engineer II in Richland, WA.

Navarro Research & Engineering is an award-winning federal contractor dedicated to partnering with clients to advance clean energy and deliver effective solutions for complex challenges in the nuclear and environmental fields. Joining Navarro means being a part of an exceptional team committed to quality and safety while also looking for innovative strategies to create value for the client’s success. Headquartered in Oak Ridge, Tennessee, Navarro has active programs in place across the nation for DOE/NNSA, NASA, and the Department of Defense.

This position will support Navarro-ATL. Navarro-ATL is located in Richland, WA, and operates, manages, and maintains the 222-S Laboratory Complex for the Department of Energy. The Navarro-ATL members are Navarro Research and Engineering, Inc. (Oak Ridge, TN), and Advanced Technologies and Laboratories International...

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Associate I based onsite in our Tewksbury, MA facility.  CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets.  CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.

The Quality Assurance Associate I is responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components in a GMP/ISO...

• Conducts Annual Drug (Product) Reviews and Device History Reviews.

• Maintains Regulatory Compliance documents and documents of external origin.
• Maintain Document Control (including Records Retention)
• Participates in internal and external audit process.
• Participates in Mock (product) recall audits.
• Maintain SOPs and Quality Forms as part of Document Control.
• Maintains records of customer-approvals documents as evidence of authenticity.
• Participate in QA Audits and draft reports of such audits.
• Effects changes to specification sheets as approved through change control requests.
• Support Change Control program and maintain evidence of product and process changes.
• Maintains SOP binders and updates such documents through approved CCs.
• Supports EWL Employee training and documentation.
• Maintains suppliers and vendors qualification program.
• Supports and...