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GMP Technical Writer

Company: Eurofins PSS Insourcing Solutions
Location: West Point
Posted on: April 10, 2021

Job Description:

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2019, Eurofins generated total revenues of EUR --- 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Eurofins Professional Scientific Services is searching for a Production Specialist to support our client in West Point, PA.

Production Specialist responsibilities include, but are not limited to, the following:

  • Support pilot plant operations for the GMP manufacturing of sterile, biologic, and vaccine clinical supplies.
  • Lead and/or participate in various pilot plant process improvement projects with respect to compliance, efficiency, etc., working with cross-functional teams (e.g. operations, engineering, EM, quality, etc.)
  • Revise/author GMP documentation (e.g. SOP's, logs, etc.).
  • Conduct investigations of minor deviations (NOE's) and author associated reports.
  • Create and review logbooks and other GMP documentation; collaborate with hourly and salary staff for corrections as needed.
  • Review utility reports and troubleshoot as necessary
  • Manage/maintain department production metrics
  • Support GMP, safety, and training initiatives Qualifications

    The Ideal Candidate Would Possess
    • Analytical problem solving skills
    • Cross functional leadership skills
    • Technical writing experience - including batch documentation, investigations, protocols
    • A good understanding of the regulatory guidelines governing GMP and sterile manufacturing.
    • Project management experience

      Basic Minimum Qualifications
      • Bachelor's/Master's degree in engineering, biomedical engineering, chemistry, biology, or related field
      • Minimum of 2 years in a technical or operations support role
      • Sterile process manufacturing and/or formulation development
      • Knowledge of manufacturing equipment and Good Manufacturing Practices
      • Authorization to work in the United States indefinitely without restriction or sponsorship

        Additional Information

        Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of West Point, PA 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer

Keywords: Eurofins PSS Insourcing Solutions, Tuscaloosa , GMP Technical Writer, IT / Software / Systems , West Point, Alabama

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