Manufacturing QA Associate (2nd Shift)

The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing.

• Use fundamental knowledge of GMP and established procedures methodologies to provide quality oversight of manufacturing documentation housekeeping and overall GMP compliance
• Ensure the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions
• 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 assist in investigations
• Work in cross-functional teams to meet and exceed timelines
• Execute or review room and line clearances
• Make quality decisions in real-time according to regulations ICH Q7 and 21CFR211 and internal procedures
• Support/initiate analytical test results initial investigation on the floor
• Reviews and may approve manufacturing analytical testing on the floor

Qualifications :

• Bachelors Degree in Microbiology or related field (e.g. microbiology chemistry biological sciences bioengineering etc.)
• Bachelors degree and 2-4 years of relevant experience or a Masters degree and up to 2 years of relevant experience
• Quality Assurance in GMP facilities drug substance preferred
• Batch record review housekeeping monitoring GMP document review and/or creation.
• Reviewing deviation reports change controls CAPA and analytical data.
• Experience with Data Integrity
• Knowledge of and experience in GMP following applicable regulations or willingness to become GMP proficient

Additional Information :

This position is Full-Time Monday-Friday 3pm-12am. Candidates currently living within a commutable distance of Sanford NC are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time