Stability Compliance Specialist

Company: Eurofins USA
Location: Fremont
Posted on: January 15, 2021

Job Description:

Consider joining Eurofins Lancaster Laboratories where people are the most important element in our chemistry. Celebrating 50 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.Eurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for a Stability Compliance Specialist to support our Professional Scientific Services group in Fremont, CA.Job DescriptionStability Compliance Specialist responsibilities include, but are not limited to, the following: * Work cross functionally to provide quality oversight of Phase I and II GMP readiness, including production readiness, material qualification, strategy for testing of raw materials, supplier qualification, etc.* Develop, deliver, evaluate and outline the quality strategy to meet US, European, and global Good Clinical Practice (GCP), Good Pharmacovigilance (GVP), and Good Laboratory Practice (GLP) requirements as part of a comprehensive and robust quality oversight program to support Phase I and II manufacturing* Stay up to date on latest FDA, EMA, and other regulatory updates applicable to Phase I and Phase II medicinal products* Collaborate cross-functionally with the Quality and Analytical Departments* Review procedures and provides input and feedback to promote continuous improvement risk assessment, batch records, testing specification, etc.* Present and explain complex technical concepts and tasksThe ideal candidate would possess:* QA experience in a GCP/Quality System environment with a working knowledge and ability to apply GCP, GVP and GLP in conformance with US, EU and international standards* Experience developing the quality strategy for Phase I-II medicinal products* Experience in project management and ensuring project work aligns with established practices, policies, and processes* Experience and ability to make continuous process improvements* Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience* Experience with audits and/or regulatory inspections is a plus* Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team player in a fast-paced working environment* Strong computer, scientific, and organizational skills* Excellent attention to detail; excellent time management skills; and ability to elevate relevant issues to project lead and line-management* Ability to work independently and as part of a team with internal and external clients, 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 policiesQualifications* Bachelor's degree in related scientific field* 8+ years of experience in a cGMP or quality environment* Experience developing quality strategy for Phase I or II medicinal products* Authorization to work in the United States indefinitely without restriction or sponsorshipAdditional InformationPosition is full-time, Monday through Friday (8 a.m.-5 p.m.), with overtime as needed. Candidates currently living within a commutable distance of Fremont, California are encouraged to apply.As a Eurofins Lancaster Lab PSS employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.To learn more about Eurofins Lancaster Laboratories, please explore our website www.lancasterlabs.com.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.SDL2017

Keywords: Eurofins USA, Fremont , Stability Compliance Specialist, Other , Fremont, California