Manufacturing QA Associate

4 weeks ago


Sanford North Carolina, United States Eurofins USA PSS Insourcing Solutions Full time
Job Description

POSITION SUMMARY:

The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing. The colleague uses fundamental knowledge of GMP, and established procedures methodologies to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.  The Associate ensures the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions.

CORE JOB DUTIES:

Performs duties with the guidance of Sr. Associates

Execute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance

Support Transfer Master Cell Banks to Manufacturing

Perform housekeeping and GMP walkthroughs of facility

Initiate deviations in real time and assists in investigations

Work in cross functional teams to meet and exceed timelines

Execute or review room and line clearances

Makes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedures

ADDITIONAL RESPONSIBILITIES

Support/initiate analytical test results initial investigation on the floor

Reviews and may approve manufacturing analytical testing on the floor

Uses analytical skills to help ensure shop floor compliance to internal standards and procedures

Draft and review Standard Operating Procedures

Work independently and with minimal supervision

Provides excellent communication

Perform other duties as assigned and take ownership to support the implementation of activities needed including but not limited to facility start-up and continuous operations.



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