Quality Assurance Specialist

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

Data Analyst responsibilities include, but are not limited to, the following:

• Review laboratory data to ensure all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices
• Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia). 
• Approve Master Laboratory worksheets prior to issuance to Laboratory Operations.
• Represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor
• Work closely  with  the  assigned  laboratory in  a  team  environment  to  ensure  timely  reviews of documentation and to ensure that documentation is completed right the first time. 
• Work with Laboratory Operations staff and management to remediate comments and errors in documentation. 
• Assist Laboratory Operations in conducting investigations associated with laboratory data review. 
• Utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements. 
• Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
• Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates.  Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.
  •  Maintain metrics and tracking associated with these documentation reviews.
  • Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
• Perform review and approval of qualification documents as needed.
• Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
• Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
• Responsible for issuance of new and reconciliation of completed laboratory worksheets
• Foster a customer service attitude within Laboratory Operations
• Provide support to Regulatory Agency inspections as needed.

Qualifications

Qualifications

The ideal candidate would possess:

• Bachelors Degree in life science, scientific discipline or engineering. MS in life science or engineering.
• In lieu of a Life Sciences or other Bachelor’s degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.
• Minimum 1-2 years experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing