Quality Assurance – Senior Specialist Position Available In Montgomery, Pennsylvania
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Job Description
Company DescriptionEurofins 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 DescriptionFunction as the lead auditor both independently and as part of a team to ensure compliance to GxPs, client policies, international guidelines and departmental SOPsProactively identify and analyze quality indicators and data to identify potential risks and create risk management strategiesConduct 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 toolsEscalate quality issues in a timely manner to leadership, participate in root cause and CAPAsProvide timely resolution of findings and reports to appropriate personnel and leadershipStay away of regulatory citations and other pertinent information to distribute to personnel, may participate in compliance awareness sessionsTrain other QA colleaguesProvide inspection management support as neededComplete other projects or assignments as directed by management
QualificationsMinimum Qualifications:
BS/BA degree in a scientific concentration10 years of previous QA experience in the pharmaceutical industry, experience in a broad range of auditingAuthorization to work in the United States indefinitely without restriction or sponsorship
Desired Qualifications:
Business acumen, strong understanding of pharmaceutical industryAbility to prioritize and plan out projects, establish detailed action plansIdentify and understand complex problems, analyze and seek out solutionsNetwork and build partnerships across work groupsAdditional InformationPosition 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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.