Senior Analyst 1, QC Raw Materials

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Senior Analyst 1 QC Raw Materials 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 raw material testing and disposition using the established analytical methods.

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

What Youll Do

Under supervision support raw material life cycle management (new material assessment specification establishment maintenance of specifications etc.).
Supports QC Raw Materials team on internal tech transfer meetings related to new products.
Under supervision and support authors and reviews procedures protocols reports and specifications related to the raw material area.
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 and execution of Trackwise deviations CAPAs lab exceptions and invalid assays.
Authors and implements corrective and preventative actions from approved deviations CAPAs 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 Manager QC in the implementation of new technologies.
Adheres to predefined turnaround times of raw material 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.

Minimum Qualifications

Bachelors Degree degree in Chemistry Biology Microbiology Biochemistry or other relevant scientific discipline.
13 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 with 0 years experience.
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 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 Senior Analyst 1 QC Raw Materials 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 ...