Sr. Specialist 2, QC Technical Transfer and Sample Support

Position Overview

About the Role

The Sr. Specialist 2, QC Program Management 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 2, TT / SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in and leads collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

Job Description

What You\'ll Do

• Collaborates with customers and stakeholders from QC and DSM to support tech transfers of new customer projects as they relate to QC Sample Plans and DS / DP Specifications.
• Authors, reviews, and leads updates of controlled GMP documents related to QC Sample Plans and QC Specifications.
• Leads, authors, and reviews change controls of QC Sample Plans for both internal and external changes together with relevant stakeholders, including communication with customers as applicable.
• Manages and directs the continuous improvement of QC Sample Plans and QC Specifications.
• Applies holistic quality system approach through identifying and solving technical and compliance gaps and areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation.
• Leads and 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.
• Provides guidance and feedback for QC personnel development.
• Performs other duties, as assigned.

Minimum Requirements

Preferred Requirements

Working & Physical Conditions

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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 place. 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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