Senior Specialist 1, Quality Control Tech Transfer & Sample Support

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 Specialist 1 Quality Control Technical Transfer(TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders including customers. The Sr Specialist 1 TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

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:

Collaborates with customers and stakeholders from QC and DS Manufacturing (DSM) to support tech transfers of new customer projects as they relate to QC Sample Plans and DS/DP Specifications
Participates in updates of controlled GMP documents related to QC Sample Plans and QC Specifications
Participates in writing and review of change controls of QC Sample Plans for both internal and external changes together with relevant stakeholders including communication with customers as applicable
Manages continuous improvement of QC Sample Plans and QC Specifications as needed
Applies holistic quality system approach through identifying and solving technical and compliance gaps.
Identifies areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation
Participates in team compliance activities including writing changing and maintaining GMP documents in collaboration with relevant stakeholders and QA
Ensures compliance with platform procedures and global QC vision. Supports management in training compliance with policies and inspections. Supports regulatory requests audits and inspections
Collaborates with the LIMS team and IT department to build DS/DP sample plan and specification functions that meet end-user and customer requirements
Performs other duties as assigned

Required Skills:

Excellent verbal and written communication skills and attention to detail
Ability to lead improvement projects
Ability to analyze and present data and technical information to others outside of the team
Ability to solve complex challenges and assist others as needed
Ability to think strategically plan and implement improvements
Primary contact for clients in the laboratory and eagerness for enhancing customer satisfaction
Self-driven and dedicated with excellent time management skills
Flexible with a positive attitude and positive energy; seeks challenges and opportunities
Ability to work cross-functionally with a diverse team
Must be flexible to support 24/7 manufacturing facility

Education/Experience Required:

Bachelors in Biological Sciences Engineering or related science field with 2 years of relevant experience OR
Masters in Biological Sciences Engineering or related science field with 0 years of relevant experience
Prior experience with project management in biotechnology Pharma Contract Research Organization (CRO) or Contract Laboratory Organization (CLO)
1-3 years experience in a GMP environment.
Prior experience in leading technical writing initiatives.

Education/Experience Preferred:

Masters in Biological Sciences Engineering or related science field with 1 year of relevant experience
Experience with Customer Relationship Management
Prior drug substance or manufacturing experience including process validation transfer commercialization and manufacturing support and troubleshooting.
Experience using quality systems (e.g. deviation management system change control corrective and preventive action (CAPA) document management system)
Prior experience in participating in project improvement management.
LEAN/6S certification

Physical Requirements/Working Environment:

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 use 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.

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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 Technical Transfer(TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders including customers. The Sr Specialis...