Quality Systems Analyst
Georgia, VT, US, 05468
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to win in self-care.
Description Overview
The Quality Systems Analyst - Stability position is responsible for administering the PVT / POH finished product stability testing programs. The basic functions of the position are to, in conformance w local procedures, select batches for stability testing, obtain and store samples, create stability studies in the system software of record, periodically release samples to the laboratory, and monitor compliance of ongoing studies.
This is a first shift opening, Monday to Friday, 8am - 4:30pm.
Scope of the Role
- Maintain the documents (SOP, WI, forms) which describe the local stability requirements and the use of the software system of record (SLIM).
- Based on these routine requirements, experimental protocols, etc., select batches for stability testing, and obtain and store the necessary samples.
- In the software system of record, SLIM, create stability studies, based on these local requirements, experimental protocols, etc.
- On a weekly basis, determine what samples need to be placed on test; locate, process, and deliver the samples to the QC Laboratory.
- As a component of ongoing stability testing, maintain and conduct QA Sensory panel analysis.
- Monitor and maintain the commercial stability sample storage area; store new samples and discard old samples on an ongoing basis.
- Monitor the ongoing testing of stability samples in the software system of record, SLIM; advise QC management of overdue testing, etc.
- Explain the stability program to internal and external auditors.
- Perform other duties as assigned.
Experience Required
- Bachelor’s Degree in Food Science, Chemistry, Biology, or a related science, or equivalent work experience in a related field.
- Experience working in a regulated industry and strong understanding of interpreting regulatory requirements.
- Minimum of 3-5 years of related Quality experience
- Exposure to 21 CFR Parts 106, 107, 110.
Skills:
- Working knowledge of infant formula fortification, the relevant forms and levels of various nutrients, and the laboratory test methods used to measure them.
- Knowledge or experience in Microsoft Office programs, SAP QM; Stability Laboratory Information Manager (SLIM) software experience is preferred.
- Training in or previous experience with database management, structured programming, etc. is preferred
Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
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We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo
Nearest Major Market: Burlington Vermont