GMP Technical Writer
Company: Eurofins PSS Insourcing Solutions
Location: West Point
Posted on: April 10, 2021
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.
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
- Create and review logbooks and other GMP documentation;
collaborate with hourly and salary staff for corrections as
- Review utility reports and troubleshoot as necessary
- Manage/maintain department production metrics
- Support GMP, safety, and training initiatives
The Ideal Candidate Would Possess
- Analytical problem solving skills
- Cross functional leadership skills
- Technical writing experience - including batch documentation,
- 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
- Sterile process manufacturing and/or formulation
- Knowledge of manufacturing equipment and Good Manufacturing
- Authorization to work in the United States indefinitely without
restriction or sponsorship
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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