Manufacturing Qa Senior Associate

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.