QA Project Manager

Eurofins; West Point (PA); Presencial; USD 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Full benefits including medical,Dental

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Descripción de la vacante

Eurofins is seeking a Lead QA Auditor in West Point, PA to independently and collaboratively audit compliance with GxP, client policies and SOPs. You will identify risks, perform GLP/BA/BE/VCA audits, and support QA procedures and audit tools. The role requires leading audits and resolving findings with leadership.

Expect to coordinate with cross-functional teams, mentor QA staff, and participate in inspections. Monday–Friday, full-time with comprehensive benefits are provided.

Formación

• BS/BA in a scientific concentration.
• 10 years QA experience in the pharmaceutical industry, broad auditing exposure.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Responsabilidades

• Lead audits independently and in teams to ensure GxP compliance.
• Identify quality indicators and risks; develop risk management strategies.
• Conduct GLP, BA/BE/VCA audits and other assignments.
• Serve as a QA resource; help develop procedures and audit tools.
• Escalate issues to leadership; participate in CAPAs and root-cause analysis.
• Provide timely findings and reports to stakeholders; support inspection readiness.

Conocimientos

QA auditing

GxP compliance

Regulatory knowledge

Audit leadership

Educación

BS/BA in science

Descripción del empleo

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 awareof 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, PAare 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.