The Fountain Group is a national staffing firm and we are currently seeking a QA Specialist III for a prominent client of ours. This position is in Irvine, CA 92612. Details for the position are as follows:
Job Description:
- $44 - $47/hour, Monday – Friday 8:30AM – 5:00PM.
- Responsible for providing quality assurance support for some or all the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics.
- Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA.
- This position will ensure that all product, process, or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
- This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural Health Products, Cosmetics, Homeopathic and Over the Counter (OTC) Drugs
- Assist project teams in planning new product launches and tech transfer.
- Assist project teams in planning, preparation, review and approval of quality documentation.
- Responsible for developing a process to maintain citation history.
- Monitor changes to legislation, regulations and statutes that may impact
- Supplier oversight, assuring responsible Third Parties are complaint with cGMPs, regulatory and corporate compliance requirements and contractual agreements as applicable.
- Complete and route change requests for process document creation, maintenance, and implementation.
Qualifications:
- 4+ years of relevant experience.
- Knowledge of Cosmetic and OTC product regulations and guidance, including new product introductions and tech transfer highly preferred.
- Ability to work in a team, both in person and remotely, and across various departments.