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.

Qualifications

• A Bachelor's or Master's degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
  • Bachelor's degree + 2-4 years of relevant experience
  • Master's degree + up to 2 years of relevant experience
  • Relevant experience includes:
    • 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.
• Valid driver's license and personal transportation

Additional Information

Position is Full Time, Wednesday - Saturday, every other Wednesday off, 7:00 PM - 7:00 AM. Candidates currently living within a commutable distance of Sanford , NC are encouraged to apply.

** What we offer:**

• 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
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins USA PSS Insourcing Solutions is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.