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GMP Calibration Specialist

Company:
Eurofins USA PSS Insourcing Solutions
Location:
West Point, PA
Posted:
April 18, 2024
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Description:

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 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-5pm with over time as needed. Candidates currently living in a commutable distance to West Point, PA are 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 website

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

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