External Quality Associate Jobs in North Carolina

• Knowledge, Skill and Abilities

• Good project management skills

• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Must have basic English written and oral communication skills adequate to communicate with other team members.

• Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.

Job Title: Quality Associate III

Prior experience with drug substance and drug product manufacturing, including aseptic operations and with managing external manufacturing operations.

Upstream, downstream, fill finish and plasmid manufacturing experience preferred. A subset of this experience can be considered.

A continuous improvement mindset, with prior experience managing performance objectives, monitoring and assessing results, identifying areas for improvement, and implementing solutions.

Demonstrated project leadership skills with the ability to provide cross functional, and cross-company leadership of key initiatives.

Prior hands-on GMP operations experience, prior experience preparing for and executing manufacturing site regulatory inspections and regulatory filings.

Prior experience managing manufacturing of gene therapy products is strongly preferred.