JOB REQUIREMENTS: Company Description Interested in contributingto
improving and saving lives? Eurofins Food Chemistry Madison is growing
and we\'re looking for amazing team members to join us. In 2021 we moved
into a brand new ISO 17025 accredited laboratoryin Madison, WI designed
to conductfood chemistry testingspecializing in infant formula,
sole-source nutrition products, hemp and CBD, dietary supplements, and a
variety of botanicals. Ourtesting portfolio includes vitamins, minerals,
contaminants, pesticides and shelf-life studies. We test of a variety of
instrumentation including UPLC, HPLC, GC, and LCMS technologies. We
offer an innovative and collaborative team environment, and the
opportunity to develop expertise on a wide variety of analytical
instruments! If you are looking for an opportunity to work for an
exciting growth oriented company, we look forward to talking with you!
The GMP QA Associate is responsible for supporting the local
implementation and operation of the GMP Quality Management System. The
role aims to ensure the site remains in a state of GMP compliance
providing expert advice relating to GMP and by actively participating in
investigations, audits, data reviews, validation projects, and the
delivery of GMP related training. Job Description Essential Duties and
Responsibilities: * Reviews and approves site quality documents
(SOP\'s, Policies, etc.) to ensure compliance with GMP, Eurofins
document management procedures and other applicable quality standards *
Supports the supplier qualification program by participating in
assessments and leading third party audits * Provides regulatory
approval of study related documentation (i.e. batch records, protocols,
reports, certificates of analysis, etc) prior to release to the Client
* Supports the GMP QA internal audit program by scheduling, planning
leading, reporting, and following up of system, process and facility
audits * Participates in projects to ensure facilities, utilities,
equipment and computer systems are appropriately validated/ qualified;
approval of key validation deliverables * Deputizes for the GMP QA
Manager in Leading the Management Review Process and in hosting client
and Regulatory Authority inspections, coordinating the response to
observations and follow-up of corrective actions * Represents Eurofins
GMP QA at conferences and seminars * Batch review and release/
rejection of Active Pharmaceutical Ingredient (API) * Batch review and
release/rejection/recall of US-based Investigational Medicinal Product
(IMP) * Supports the GMP QMS, helping to ensure the site-specific
requirements are addressed. * Provides review and quality approval of
study-related documentation (e.g., protocols, reports, certificates of
analysis, methods) prior to release to the client. * Assists in support
of the GMP internal audit program by scheduling and conducting internal
audits. * Reviews and approves quality events, including deviations,
OOS investigations, change controls, and CAPA * Performs other duties
as assigned Qualifications To perform this job successfully, the
individual must be able to perform each essential duty satisfactorily.
The requirements below are representative of the knowledge, skill or
ability required. * Bachelor\'s Degree in a Pharmacy, Chemistry or
biology related discipline * Postgraduate degree (MSC or equivalent) in
science or management related discipline, preferable * 5+ years QA/GMP
experience in the pharmaceutical or related industry * In depth
knowledge of Good Manufacturing Practice Regulations * Experience of
industry quality systems/standards, e.g. ICHQ10, ISO 9000 * Excellent
interpersonal/ organizational skills, e.g. communication, decision
making, negotiating, problem solving * Experien To view the full job
description please use the link below.
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