Quality Assurance Laboratory Specialist - Eurofins Lancaster Laboratories Professional Scientific Services, LLC

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

Quality Assurance Laboratory Specialist responsibilities include, but are not limited to, the following:

• Responsible for Quality oversight for the Laboratory shop floor.
• Actively participates in the Tier process and use this forum to escalate concerns and best practices.
• Performs Quality review and approval of investigative events in Laboratory Operations.
  • Determines the effects on test result validity, for laboratory investigative events, to ensure final reportable values are representative of the product's quality.
  • Provide input on recommended CAPAs, as appropriate.
• Performs review and approval for CAPAs, QCTS commitments, change requests, investigative protocols and final reports.
• Performs review and approval of IQ/OQ/PQ documents for assigned laboratories of responsibility.
• Completes training to become a qualified auditor and performs monthly internal audits of laboratory areas.
• Writes, reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
• Provides coaching and guidance to new personnel and to Quality Specialists who are training new personnel.
• Provides support to Regulatory Agency inspections as needed.

Qualifications

The ideal candidate would possess:

• Progressive and demonstrated Quality decision making responsibility
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
• Demonstrated self-starter with capability to develop innovative solutions to challenges.
• Proven analytical aptitude, critical thinking skills and ability to apply key concepts.
• Speaks with courage and candor.
• Strong written and verbal communication skills.
• In-depth working knowledge and application of GMPs / GLPs.
• Proven ability to manage multiple projects simultaneously.
• Experience in pharmaceutical laboratory operations or related environment.

Basic Minimum Qualifications:

• Degree in Biology, Cell Biology or Virology is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
• Experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
• 8+ years in science industry experience
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00 pm with overtime as needed. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k)