Senior Analyst 1, QC Raw Materials

Fujifilm•Holly Springs, NC

6d•Onsite

About The Position

The Senior Analyst 1, QC Raw Materials is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following Tech Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods. FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. 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 degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline.
1‐3 years relevant experience.
Previous experience in a GMP environment.
Computer proficiency required.

Nice To Haves

Masters degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years’ experience.
Familiar with Raw Material methodology as it pertains to cGMP,
Experience in assay troubleshooting and problem solving

Responsibilities

Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.).
Supports QC Raw Materials team on internal tech transfer meetings related to new products.
Under supervision and support, authors and reviews procedures, protocols, reports and specifications related to the raw material area.
Performs testing and disposition of incoming raw materials and components according to specifications and procedures.
Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
Responsible for initiation and execution of Trackwise deviations, CAPA's, lab exceptions and invalid assays.
Authors and implements corrective and preventative actions from approved deviations, CAPA's, lab exceptions and invalid assays in Trackwise.
Performs routine investigations in support of out of specification testing results.
Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
Enforces established policies and procedures and escalates to management areas where enhancements will improve daily work.
Assists Manager, QC in the implementation of new technologies.
Adheres to pre‐defined turnaround times of raw material testing.
Reviews new and updated specifications.
Assesses lab exceptions and performs routine investigations.
Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
Performs other duties, as assigned.