Senior Quality Specialist at Eurofins

Lancaster, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

0.0

Posted On

06 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP, GLP, Quality Assurance, Client Service, Teamwork, Collaboration, Root Cause Analysis, CAPA, Internal Audits, Regulatory Requirements, Process Improvement, Data Review, Training Programs, Problem Solving, Quality Metrics

Industry

Medical and Diagnostic Laboratories

Description

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. Job Description Essential Duties and Responsibilities:  Applies GMP/GLP in all areas of responsibility, as appropriate  Applies the highest quality standard in all areas of responsibility  Demonstrates and promotes the company vision  Demonstrates strong client service skills, teamwork, and collaboration  Proactively plans and multitasks to maximize productivity  Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration  Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories  Demonstrate understanding of QAU operations and functions  Perform investigation writing and review including thorough root cause analysis and CAPA  Perform internal audits and walk through inspections  Review procedures, methods and protocols  Release analytical reports  Host client audits, appropriately respond to findings and recommendations  Provide information/entries for monthly/quarterly quality reports to management  Conducts all activities in a safe and efficient manner  Communicates effectively with clients and staff members  Take initiative to diagnose problems, solve simple problems, and present suggestions for solutions to complex problems  Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes  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 interpretation of regulations  Assist and/or prepare and present training programs as needed to satisfy regulatory requirements  Serve as mentor to specialists to successfully complete assignments  Identify and drive process 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 while remaining compliant.  Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents  Demonstrate understanding of laboratory data or metrics, identify issues and provide options for resolution  Effectively lead quality metrics discussions with the technical/support team, demonstrating an understanding of the data being presented and suggesting areas of improvement based on trends identified.  Perform GLP inspections and data review for assigned projects  Performs other duties as assigned Qualifications Minimum Qualifications: Bachelor's degree in science-related field with four years related industry experience including some Quality Assurance responsibilities Minimum of four years of laboratory or QA related experience Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information Position is full-time, Monday-Friday 8am-5:00pm, plus additional hours, as needed. Candidates within a commutable distance of Lancaster, PA 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.

Responsibilities

The Senior Quality Specialist applies GMP/GLP standards and ensures the highest quality in all areas of responsibility. They perform investigations, internal audits, and contribute to continuous quality improvement within the QA department and laboratories.