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