QA Supervisor, Product Release

Fujifilm•Santa Ana, CA

1d•$103,093 - $134,204•Onsite

About The Position

We are hiring a QA Supervisor, Product Release. The QA Supervisor, Product Release will manage and lead the Quality Assurance (QA) Product Release personnel and activities and ensure timely review and processing of batch records. At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences. Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Bachelor’s degree required, preferably in a science-related fieldsuch as Biology, Chemistry, Biotechnology, or related discipline
A minimum of five (5) years of direct QA experience in the medical device and/or pharmaceutical industry.
A minimum of two (2) years in a supervisor role.
Detailed knowledge of FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada, TGA and MDR requirements.
Ability to write, edit, speak, and read English well

Responsibilities

Lead, manage, mentor, coach, train, and guide the QA Product Release team.
Lead process improvements and initiatives relevant to the QA Product Release function.
Manage the semi-finished and finished product batch record reviews, releases, and restrictions/blocks per standard operating procedure (SOP) requirements; including status updates to cross-functional departments.
Manage the department’s key performance indicators (KPI) and ensure they are being achieved.
Support the tech transfer program by creating/updating/obsoleting quality documents and assuring conformance to all quality requirements (e.g., specification development).
Support audits, customer requests, cross-functional projects, and investigations by providing documentation, assessments, data, reports, and other relevant information.
Support global requests, investigations, and projects.
Support other areas of the quality system, as needed (e.g., supplier quality and nonconformance).
Review/create/edit/approve quality documents (e.g., SOPs).
Collaborate effectively with cross-functional teams to achieve KPIs and objectives.
May be required to perform other duties as needed.