Posted on: 5/25/2023
QC Specialist -GMP - Hybrid, Eurofins USA PSS Insourcing Solutions, Remote, Cambridge, MA, USA
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 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.
Job Description
Non-lab based role, and possibility or remote work
Reviews and interprets data with support from the client and contributes to technical reports and regulatory filings.
Reviews QC testing data of small molecule and/or Biologics analytical methods generated by vendor test labs.
Supports vendor OOS/ATI/Investigations, verifies that data meets current specifications, generates COA(s), and tracks cycle time metrics, captures related deviations, OOS, CAPAs, atypical results, change controls. May communicate with vendor test laboratories.
Trends reference standards and data as appropriate.
Initiate workflows for protocol and report uploads/approvals in relevant electronic documentation systems.
Prepares protocols/reports as appropriate/necessary
Authors or revises SOPs/technical documents with client oversight.
Assists in the planning of basic unit operations.
May perform stability coordination.
Works with department peers to execute well defined assignments.
Identifies and communicates routine technical problems and data and vendor issues within the scope of responsibility.
Makes and understands basic decisions within scope of responsibility.
Assists with method transfer and method validations at vendors as appropriate.
Build studies/enters data into a validated data repository.
Coordinates with departmental peers on project work as appropriate.
Qualifications
Bachelor degree in Chemistry, Biology or equivalent with some relevant industry experience
Previous experience in Quality Control and/or Analytical Development preferred
Analytical and Problem Solving Skills -Able to troubleshoot routine issues or problems using appropriate information
Working knowledge of GMP compliance
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Cambridge, 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.