Microbiology Deviations Author

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

Group's key figures (as of March 2020) are approx. 5.4 billion Euros turnover, over 800 laboratories across 50 countries and about 50,000 staff.
Job Description

Employee Responsibilities:

• Operate as part of a deviations management team
• Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented
• Review data audits
• Author reports as needed
• Ensure investigations adhere to the compliance-driven timeline
• Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations guidelines, and policies/procedures.
• Support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility.
• Support laboratory investigations including identification of root cause, identification and implementation of corrective and preventative actions, and authoring the final investigation report

The Ideal Candidate would possess:

• Laboratory background in Microbiology
• Root Cause Analysis expertise preferred
• Attentiveness to detail
• Experience with GMP documentation practices and a strong understanding of GMP practices in the instructions, and comply with company policies
• Industry deviation Management experience preferrred
• Technical writing expertise preferred
• Excellent communication skills- with oral and written
• Strong organization and attention to detail
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies (GMP knowledge a plus)
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Qualifications

Minimum Qualifications:

• Degree in Biology, Cell Biology or Microbiology is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
• 5+ Yeas in Science industry experience
• Experience Troubleshooting Laboratory Deviations
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

What we offer:

• 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 Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Position is full-time, Monday through Friday, 8 a.m. to 5 p.m., with overtime and weekends as needed. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.