Senior Compliance Specialist

Eurofins Scient. Devens , MA 01434

Posted 3 weeks ago

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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

In 2020, Eurofins generated total revenues of EUR 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

The Next Generation Therapeutics group is a newly formed team with a focus on using novel therapeutic modalities to deliver medicines for chronic pain and neuro degenerative disorders. The group, based at our Cambridge Innovation Center in Kendall Square, will work with internal and external partners to identify and deliver new novel therapies into patients at speed. The team is seeking experienced and inspiring scientists to join our fast-paced, interdisciplinary team as we leverage innovative RNA/oligonucleotide/gene and genomic based therapeutic modalities to enhance our portfolio.

Responsible for the execution and analysis of experiments and analytical procedures. Display a technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigate basic technical problems with instrumentation and software used during analysis. Independently performs routine scientific procedures and experiments after initial guidance and planning. Plan and prioritize concurrent experimental procedures. Integrate, compile, and tabulate data and assist supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Work under active supervision. Follow established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contribute to the completion of milestones associated with specific projects

  • Performing Quality review of equipment installation, operation, and performance qualification protocols. Qualifications will be for production equipment (reactors, filters, ovens, etc.), analytical instrumentation (HPLC/UPLC, GC, etc.) and site utilities (HVAC, Purified Water, Nitrogen, etc.)

  • Performing Quality approval of executed equipment qualification protocols

  • Providing oversight of Supplier Management program and ensuring that required activities are completed

  • Assisting in gathering site Key Performance Indicators (KPIs)

  • Providing audit assistance for regulatory inspections and routine customer audits as well as performing internal audits

  • Assisting management with providing responses and CAPAs to audit observations

  • Working with other departments to develop and implement various trainings

  • Working on compliance related deviations/investigations, CAPAs and Changes as either owner or QA oversight

  • BS in a scientific discipline or equivalent with a 6+ years' experience in an FDA regulated industry; MS in a scientific discipline or equivalent with a 5+ years' experience in an FDA regulated industry

  • Experience with Quality Assurance oversight

  • Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations

  • Experience with Microsoft Office and other complex computer software

Position is full-time, Monday

  • Friday 8:00am

  • 5:00pm. Candidates currently living within a commutable distance of Devens, MA 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.

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Senior Compliance Specialist

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