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GMP Calibration Specialist

4 months ago

Worcester, Massachusetts, United States Eurofins Full time

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
  • Ensure all calibrations are completed on time and accurately
  • Coordinate and oversee outside vendor calibration and PM activities with external vendors
  • Enter Equipment Calibration/PMs in appropriate software
  • Support with equipment validation activities if/as required
  • Have conceptual knowledge to troubleshoot issues with analytical laboratory equipment prior to service calls
  • Manage the Master Equipment List as required
  • Assist with equipment related GMP documentation (maintain accurate equipment logs, cal certs, authoring SOPs, assist with Out of Service tagging, set-up of new equipment, and commissioning activities)
  • Initiate work orders as required for equipment, facility, and safety matters.
  • Perform monthly and quarterly alarm trending
  • Perform equipment retirement change controls
  • Perform periodic reviews of equipment and laboratory PCs and ensure laboratory computer systems back up weekly in the Image and Data software
  • Perform electronic and paper logbook checks
  • Actively participate in a daily touchpoint meeting and perform all training on-time
  • Participate in and/or lead projects to continuously improve processes
  • Signal problems or opportunities in the business
  • Provide support in the maintenance of the laboratory working environment including:
    • Cleanliness of common laboratory area
    • Management of waste for collection
    • Co-ordination of laboratory supplies (reagents / consumables)
Qualifications

The Ideal Candidate would possess:
  • Strong knowledge in cGMP and compliance guidelines
  • Proven experience in equipment installation, qualification and maintenance
  • Ability to keep overview of tasks and set priorities
  • Continuous Learning Attitude and preferable Lean Six Sigma/ Continuous Improvement mindset
  • Computer literacy knowledge (e.g. MS Office, ProCal, Veeva Vault, Acronis, KNEAT, MEDs, SAP)
  • Strong focus on clients and end-user
  • Ability to work under minimum supervision
  • Team work oriented
  • Flawless Integrity Mindset
  • Strong interpersonal and communication skills, oral and written
Minimum Qualifications:
  • Bachelor's degree in biology, chemistry, engineering or other related field
  • Minimum of 3 years of relevant experience in the pharmaceutical industry and cGMP.
  • Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information

Position is full-time and permanent,Monday-Friday, 8am-5pmwith over time as needed.Candidatescurrently living in a commutable distance toWest Point,PAare encouraged to apply. On-site work is expected in order to be effective in this role.

What we offer:
  • 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
  • Yearly goal-based bonus & eligibility for merit-based increases
Eurofins Lancaster Laboratories Professional Scientific Services(PSS) is a global, award-winning insourcing solution that places our people at our clients' site 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 great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.