Analyst 1, QC Compendial Testing

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Analyst 1, QC Compendial Testing 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 compendial testing, including raw material analysis and disposition using 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

Excellent attention to detail. Looks for opportunities for continuous improvement.
Basic technical writing and problem-solving skills.
Excellent verbal and written communication skills.
Able to manage and complete tasks according to a structured plan.
Able to complete tasks both independently and with occasional guidance from Supervision.
Ability to support audit readiness for the laboratory.
Self-driven, dedicated, and systematic and can plan your day in a structured way.
Flexible, has a positive attitude, positive energy and open for changes and interested in developing yourself.
Understanding of GMP, GLP, GDP requirements.
Knowledgeable in basic sciences and Microbiology laboratory methods and procedures.
Ability to work cross-functionally with a diverse team.
Self-motivated and collaborate with junior team members.
Ability to quickly learn and understand the knowledge of procedures and practices in assigned area.
Familiarity with fundamental statistical tools to analyze data in relation to trends results.
Basic understanding and familiarity with data management systems such as Trackwise or LIMS or capability to learn basic use and navigation within the systems.
Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.
Must be flexible to support 24/7 manufacturing facility.
Bachelor’s Degree in Chemistry, Biology, Microbiology, Biochemistry or related 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.
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 Compendial Testing team on internal tech transfer meetings related to new products.
Under supervision and support, authors and reviews procedures, protocols, reports and specifications related to compendial and raw material testing.
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 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 the QC Manager in the implementation of new technologies.
Adheres to pre‐defined turnaround times of compendial 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.