Senior Specialist 1, Quality Control Instrumentation (61)

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Quality Control Senior Specialist 1 Instrumentation works independently to perform routine operations continuous improvement and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role ensures the performance of routine maintenance completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role supports stakeholders with issues and guidance related to QC analytical instruments. This role is included in routine on-call and weekend support as needed.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

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

Education/Experience Requirements:

Bachelors degree in Science preferably Chemistry Biochemistry Microbiology Biology or Life Sciences relevant scientific discipline with 2 years of relevant experience OR
Masters 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 Requirements:

Experience with KNEAT software
Experience qualifying analytical instruments

Working Conditions/Physical Requirements:

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 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 using twisting motions
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 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

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

Senior IC

Position OverviewThe Quality Control Senior Specialist 1 Instrumentation works independently to perform routine operations continuous improvement and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity ...