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

What You’ll Do

• 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.

Knowledge, Skills, and Abilities

• 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.

Minimum Qualifications

• 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

Preferred Qualifications

• 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.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. 
• Will work in warm/cold environments (5C).
• Will work in small and/or enclosed spaces.  

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

*LI-Onsite

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).