Manufacturing QA Associate - 12 Hour Day Shift - Eurofins PSS Insourcing Solutions, LLC

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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.

BASIC QUALIFICATIONS

• A Bachelor's or Master's degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.). 
  • Bachelor's degree and 2-4 years of relevant experience
  • Master's degree and 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.
• A valid drivers license and personal transportation 

• Candidates located within a commutable distance of Sanford, NC are encouraged to apply. 
• Schedule: 12 hour shifts, Wednesday through Saturday; Sunday -Tuesday rotation; days - 7am-7pm
• 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
• #LI-EB1

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