Deviation Management

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 DescriptionInvestigations author responsibilities include, but are not limited to, the following :

Operate as part of a LVV technical support 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

Potential support required in technical oversight of Virology quality control assays

Potential support in providing analytical change management support for Virology testing labs

Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, regulation, and policies/procedures

Potential support in coordination of analytical changes for Virology testing labs

Support key commitments for analytical change within Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility

QualificationsThe ideal candidate would possess :

Laboratory background (Biochem, Micro, Chem, Virology, etc.)

Strong computer, scientific, and organizational skills

Excellent communication (oral and written)

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Ability to learn quickly, perform multiple tasks simultaneously, keep accurate records, followinstructions, and comply with company policies

Attentiveness to detail

Experience with GMP documentation practices and a strong understandingof GMP practices in theinstructions, and comply with company policies

Technical writing expertise preferred

Industry deviation Management experience preferred

Root Cause Analysis expertise preferred

Basic 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

Experience in Technical Writing

Authorization to work in the United States indefinitely without restriction or sponsorship

Additional InformationPosition is full-time and permanent, Monday-Friday, 8am-5pmwith over time as needed.Candidatescurrently living in a commutable distance to West Point PAare encouraged to apply. On-site work is expected in order to be effective in this role.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

Yearly goal-based bonus & eligibility for merit-based increases

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 websitewww.eurofinsus.com.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.