Senior Quality Specialist

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.

Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate

Perform internal quality assurance audits

Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes

Perform review and approval of SOP's

Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretations

Provide information and revision support for updating company publications including quality policy manuals, company web site, and newsletters

Identify and drive system improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity

Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reports

Perform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolution

Review QC data and non-conformance issues for assigned technical groups, evaluate for trends or patterns

Investigate and document QA, method, and regulatory deficiencies within the lab; take investigation to next level when needed; diagnose and solve problems independently

Implement and document computer program changes, review computer system documents, provide feedback to meet regulatory and industry expectations

Strong computer, scientific, quality orientation, and organizational skills

Excellent communication (oral and written) and attention to detail

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

Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Word processing, spreadsheets, PowerPoint, and database experience

Previous GMP, Root Cause Analysis, and technical writing experience

Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)

Minimum three years of laboratory experience with knowledge of regulatory requirements

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

Position is Full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, Pennsylvania are 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 BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.