GMP Data Reviewer

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 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.

• Water Systems
  • GMP review of microbiological testing of the facility and/or laboratory water purification system samples. Tests included are LAL and Bioburden.
  • GMP review of analytical testing of the facility and/or laboratory water purification system samples. Tests included are TOC, Conductivity, EU WFI Chemical Testing.
  • GMP review of Qualification and Media Release testing.
  • GMP review of facility cleaning data and in-processing testing, including but not limited to endotoxin, bioburden, BI, HPLC, Protien Concentration, pH and Osmolality.
  • Initiation and follow-up of exceeded alert and action limits per procedures.
  • Participate in preparation of quarterly trending reports​
• Raw Materials
  • GMP review of general appearance/identifications and FTIR
  • GMP review of house gas/air sampling and testing
  • Initiation and follow-up of OOS and action limits per procedure
  • Electronic and physical receipt, log-in and distribution of samples and testings materials coming into QC.
  • Discarding / completing sample custody chain
  • Preparation and shipping of sample/materials
  • Aliquoting of bulk samples, assay standards, assay controls and custom assay reagents
• Laboratory Support
  • Assist in updating and writing SOP's
  • Routine calibration and maintenance of laboratory equipment which includes pipettes, balances, plate readers and pH meters
  • Cleaning of incubators, laminar flow hoods and biosafety cabinets
  • Cleaning of refrigerators and cold rooms
  • Defrosting of freezers
  • Disinfectant preparation
  • Maintenance of solvent wash bottles
  • Cleaning of water baths
  • GMP lab sweeps
  • Equipment out-of-tolerance (OOT) and refrigerator, freezer, incubator and pipette investigations
  • Weekly distributed control system (DCS) documentation review and maintenance
  • Participate as required in any investigations associated with their deliverables supporting this task order

• B.S. degree with 1 year of Quality Control experience in the Pharmaceutical industry
• Experience in a Quality Control Lab is preferred
• Work experience in a cGMP environment is required
• Experience with Microsoft Word and Excel is required
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Authorization to work in the United States indefinitely without restriction or sponsorship

What to Expect in the Hiring Process: 

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

Additional Details: 

The position is permanent, on-site and full-time, Monday-Friday from 7 am-3 pm. Candidates living within a commutable distance of King of Prussia, PA, and the surrounding areas are encouraged to apply. 

Excellent full-time benefits include:

• comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holiday

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our clients’ quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.