Senior Specialist 1, Quality Control Lab Support

Position Overview

The Senior Specialist 1, Quality Control Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part of a team, with growing cross-functional collaboration.

Company Overview

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:

Job Description

What You'll Do:

• Initiates and authors deviations, CAPA's, and change controls for the functional groups within QC
• Initiates and supports actions for implementation of solutions, process improvements and CAPAs
• Participates in customer interactions to gain exposure to topics such as changes, deviations, or other issues and gathers data for status overviews and reports deviations upon completion of training and observation
• Reviews and updates stability protocols, sample plans, and specifications related to Drug Substance and Drug Product updates for controlled GMP documents related to sample plans and specifications
• Coordinates technical projects and performs problem-solving learning to apply analytical and QC improvement methodologies
• Participates in cross-functional team meetings to gain exposure to QC's role in various business processes
• Supports QC laboratories in method troubleshooting efforts by collecting data and assisting team members
• Owns changes in support of QC laboratories through the change control processes, and compliance-related documentation
• Performs continuous improvement activities by developing awareness of quality systems and identifies potential areas for improvement
• Provides recommendations to management on KPI's as needed to evaluate the changes made
• Assists team members in Contract Laboratory (CLO), communication roles, learning about issues such as OOS's and deviations and compiles data for performance and status reports
  Interacts with clients as needed to support change controls and deviations
• Documents sample receipt, storage, and movement in Labware LIMS and/or internal sample chain of custody forms or logbooks
• Identifies and escalates sample issues to appropriate parties
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR
• Master's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years of relevant experience
• 1- 3 years relevant experience, experience in a GMP environment
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point)
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
• Excellent verbal and written communication skills and attention to detail
• Thorough understanding of the pharmaceutical/biotech testing
• Ability to work with minimal supervision
• Proven ability to understand and implement data integrity standard and regulations
• Proven ability to conduct investigations, writing deviations and CAPA's
• Proficient technical writing and problem-solving skills required
• Ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success
• Must be flexible to support 24/7 manufacturing facility

Preferred Requirements:

• Experience with KNEAT software
• Experience qualifying analytical instruments

Working & Physical Conditions:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 60 minutes.
• Ability to sit for prolonged periods of time up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

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.

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EEO Information

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.

ADA Information

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 ([email protected]).