Job Description

_ 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
• 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.
• Authorization to work in the United States indefinitely without restrictions or sponsorship

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm. 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.