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Pharmaceutical QA/QC Senior Specialist

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Job Description - Pharmaceutical QA/QC Senior Specialist

Company Description

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.

Job Description

 This role is in Sanford, NC.

POSITION RESPONSIBILITIES:

  • Review and approve QA documentation including validation protocols, method transfers, and compendial assessments.
  • Provide final QA approval for change controls, CAPAs, deviations, and lab investigations (OOS/OOT/OOE)
  • Support electronic record reviews and compendial change documentation.
  • Make real-time quality decisions in compliance with cGMP and regulatory standards.
  • Collaborate cross-functionally to resolve technical and quality issues.
  • Contribute to start-up activities and performed additional QA duties as needed.

Qualifications

  • Bachelor's or Master's Degree in relatable field (Microbiology, Chemistry, Pharmaceuticals, etc.)
    • Bachelor's degree and 6-8 years of experience 
    • Master's degree and 4-6 years of experience 
      • Experience in a cGMP microbiology lab is required as well as familiarity with USP, JP, and EMEA standards.
        • Strong understanding of data integrity, root cause analysis, and quality systems (deviations, CAPAs, change controls)
        • Prior QA experience supporting QC documentation investigations
        • Effective team player with strong communication and problem-solving skills
  • Valid drivers license and personal transportation
  • Authorization to work in the United States indefinitely without restriction

Additional Information

Position is full-time, Monday-Friday, 8am-5pm Candidates currently living in a commutable distance to 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.

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