Senior Specialist 1, Quality Control Lab Support

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

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 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:

Initiates and authors deviations CAPAs 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 QCs 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 KPIs as needed to evaluate the changes made
Assists team members in Contract Laboratory (CLO) communication roles learning about issues such as OOSs 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:

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
1- 3 years relevant experience experience in a GMP environment

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 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:

Senior IC

Position OverviewThe 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 collab...