FUJIFILM Biotechnologies · 5 hours ago
Senior Specialist 1, Quality Control Instrumentation
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
3+ years expFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Senior Specialist 1, Quality Control Instrumentation is responsible for the qualification, maintenance, and continuous improvement of QC analytical instrumentation, ensuring compliance with regulatory guidelines and supporting stakeholders with related issues.
BiotechnologyHealth CareManufacturing
Responsibilities
Leads the execution of the qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation, applying expertise in instrumentation, validation, and regulatory compliance
Ensures all QC equipment and instruments adhere to regulatory guidelines and site policies
Authors and critically evaluates SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports, employing advanced scientific expertise to ensure accuracy, comprehensiveness, and regulatory alignment
Champions data integrity initiatives related to analytical instruments, deploying specialized analytical skills to safeguard data reliability and compliance
Reviews and recommends appropriate user roles and privileges for data integrity (where applicable), writes instrument operation instructions and preventative maintenance plans
Coordinates with vendors, leveraging scientific insight to ensure effective maintenance and performance of analytical instruments
Completes periodic reviews of QC instruments and associated instrument control software
Proactively identifies and addresses excursions and deviations, initiating effective corrective and preventative actions (CAPAs) using independent judgment to maintain instrument integrity and compliance
Supports stakeholders, including end users, with issues and guidance related to QC analytical instruments
Works cross functionally with all end users, Validation Team, Labware Specialists, and Quality Assurance
Performs other duties, as assigned
Qualification
Required
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
Proven ability to understand and implement data integrity standard and regulations
Proven ability to conduct investigations, writing deviations and CAPA's
Superior technical writing and problem-solving skills required
The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success
Ability to perform routine on-call and weekend support, as needed
Must be flexible to support 24/7 manufacturing facility
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
3 years' relevant experience, experience in a GMP environment
Hands on experience with analytical instrumentation associated with the following technologies: UPLC/HPLC, capillary electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry
Preferred
Experience with KNEAT software
Experience qualifying analytical instruments
Ability to learn and incorporate lean lab and six sigma six principles into daily work environment
Company
FUJIFILM Biotechnologies
For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.
Founded in 2011Morrisville, North Carolina, USA
1001-5000 employees
H1B Sponsorship
FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Lars Petersen
President & Chief Executive Officer
Morten Munk
Director - Global Alliance Management
Recent News
Morningstar.com
2025-10-30
Company data provided by crunchbase