Manufacturing Qa Associate

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.