Overview
Quality Assurance – Senior Specialist Jobs in West Point, PA at Eurofins PSS Insourcing Solutions
Title: Quality Assurance – Senior Specialist
Company: Eurofins PSS Insourcing Solutions
Location: West Point, PA
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.
