Senior Quality Assurance Representative

Shift: No Department: LS-SC-UYEQS1 QA Sterility Assurance Recruiter: Katherine Hall

Hiring Manager: Austin Straw This information is for internals only. Please do not share outside of the organization.

Your Role:

This role provides day shift support as quality assurance on-the-floor oversight for manufacturing activities at the facility.

Responsibilities include but are not limited to:

• Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed.

• Performs and documents line clearances and room release for manufacturing use.

• Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented.

• Monitors the formulation and filling processes to ensure cGMP compliance.

• Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators. Requires qualification in aseptic gowning and certification as an aseptic processing SME.

• Observers, reports, and documents operator cleaning and disinfection practices.

• Documents, reports, and trends observations stemming from Quality Oversight.

• Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices.

• Monday - Friday 8am - 4:30pm.

Physical Attributes: