Specialist, Quality Control Instrumentation

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The QC Specialist Instrumentation works under the direction of senior team members to support routine operations continuous improvement and life-cycle management of the QC analytical instrumentation program. This role helps ensure compliance with Data Integrity standards following regulatory guidelines and company procedures. The Specialist assists with routine maintenance conducts periodic reviews of QC analytical instruments and helps identify and address deviations or issues. The position also involves providing support for on-call and weekend coverage when 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

Major Accountabilities:

Supports the qualification routine operation maintenance and decommissioning of QC analytical instruments.
Ensures QC equipment and instruments adhere to regulatory guidelines and site policies.
Assists in drafting and reviewing SOPs technical reports user requirements and maintenance documentation.
Participates in data integrity initiatives related to analytical instruments.
Helps recommend appropriate user roles and privileges for data integrity and assists in writing operation instructions and preventative maintenance plans.
Coordinates with vendors for maintenance activities on QC instruments.
Completes routine periodic reviews of QC instruments and their control software.
Identifies reports and follows up on excursions and deviations and assists in corrective and preventative actions (CAPAs).
Provides support and guidance to stakeholders including end users on QC analytical instrumentation.
Works cross-functionally with all end users as needed.

Knowledge Skills and Abilities:

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 CAPAs.
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.

Education and Experience Requirements:

Bachelors in relevant scientific discipline preferably Chemistry Biochemistry Microbiology Biology or Life Sciences
0-3 years laboratory experience
Prior 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 Education and Experience:

GMP laboratory experience
Experience with Kneat software.
Experience qualifying analytical instruments

Physical Requirements:

Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision including distinguishing color.
Ability to stand for up to 60 minutes.
Ability to sit for up to 60 minutes.
Ability to conduct activities using repetitive motions that includes wrists 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 small and/or enclosed spaces.
Will work in heights greater than four 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.

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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:

Position OverviewThe QC Specialist Instrumentation works under the direction of senior team members to support routine operations continuous improvement and life-cycle management of the QC analytical instrumentation program. This role helps ensure compliance with Data Integrity standards following r...