Quality Assurance - Senior Specialist

Job Description

Job DescriptionCompany 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

• Function as the lead auditor both independently and as part of a team to ensure compliance to GxPs, client policies, international guidelines and departmental SOPs
• Proactively identify and analyze quality indicators and data to identify potential risks and create risk management strategies
• Conduct a wide range of audits (such as GLP, BA/BE/VCA)
• Serve as a technical resource to resolve GLP or regulated lab area issues, actively participate in the development of QA procedures, guidance documents and audit tools
• Escalate quality issues in a timely manner to leadership, participate in root cause and CAPAs
• Provide timely resolution of findings and reports to appropriate personnel and leadership
• Stay away of regulatory citations and other pertinent information to distribute to personnel, may participate in compliance awareness sessions
• Train other QA colleagues
• Provide inspection management support as needed
• Complete other projects or assignments as directed by management

Qualifications

• Minimum Qualifications:
  • BS/BA degree in a scientific concentration
  • 10 years of previous QA experience in the pharmaceutical industry, experience in a broad range of auditing
  • Authorization to work in the United States indefinitely without restriction or sponsorship

• Desired Qualifications:
  • Business acumen, strong understanding of pharmaceutical industry
  • Ability to prioritize and plan out projects, establish detailed action plans
  • Identify and understand complex problems, analyze and seek out solutions
  • Network and build partnerships across work groups

Additional Information

Position is full-time, Monday-Friday, generally 8 a.m. - 5 p.m., weekend work might be expected. Candidates currently living within a commutable distance of West Point, PA 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 USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.