Manufacturing QA Senior Associate

4 weeks ago


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

POSITION SUMMARY:

The Senior Associate provides quality leadership and contributes to Quality Assurance on the floor activities related to drug substance manufacturing. The colleague uses their strong knowledge of GMP to provide quality leadership and oversight of manufacturing documentation, housekeeping, and overall GMP compliance. This is decision making role and provide for creative problem solving. The Senior Associate ensures the site performs in a state of compliance by leading Quality oversight activities while fostering an empowered culture of quality across all functions. 

POSITION RESPONSIBILITIES:

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

Transfer Master Cell Banks to Manufacturing

Monitor and Perform housekeeping and GMP walkthroughs of facility

Initiate, review, and approve deviations

Provide quality leadership to 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 DUTIES:

Oversees analytical test results initial investigations on the floor

Reviews and Approves Manufacturing analytical testing on the floor.

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

Oversees and leads Associates and Manufacturing colleagues as needed with non-conformances, deviations, and other issues on the floor.

Provides training to Associates on job duties, including onboarding

Work independently and with minimal supervision

Provides oversight of associates in absence of Manager

Reviews associate work

Deliver on the job training

Makes decisions for escalation of events to deviations

Support the Manager, MQA in job duties

Review Master Production Records for use in production

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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