GMP Quality Assurance Assoicate - Madison, United States - Eurofins

Description

Company DescriptionInterested in contributing to 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 laboratory in Madison, WI designed to conduct food chemistry testing specializing in infant formula, sole-source nutrition products, hemp and CBD, dietary supplements, and a variety of botanicals.

Our testing 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 youThe 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 DescriptionEssential 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

QualificationsTo 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
Experienced GMP Auditor
Experience in process improvement
Customer serviced orientated, i.e. ability to interact effectively with clients and regulatory authorities
Ability to learn new tasks
Ability to think critically and solve problems quickly and efficiently

Additional InformationPosition is Monday - Friday 8 hours a day/ 40 hours a week. In house training and on the job training will be assigned as necessary. Applicants can work remotely at times. 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.