Senior Specialist II, Tech Support & Sample Support

Fujifilm•Holly Springs, NC

10d

About The Position

The QC Program Management Technical Support (TT) and Sample Support (SS) Senior Specialist II provides technical leadership and project management for QC Sample Plans, QC Specifications, stability protocols and reports, stability sample-pull scheduling, and stability specifications. The role works closely with stakeholders and customers to support timely project milestones and deliverables, GMP-compliant laboratory operations, and compliance with regulatory guidelines. It also participates in audits and inspections and represents QC in customer discussions and cross-functional collaborations. The position supports technology transfers for new customer projects, authors and maintains controlled GMP documentation, leads change controls and continuous improvement, and addresses technical compliance gaps through sustainable corrective actions. The role also works with LIMS and IT teams to develop sample-plan, specification, and stability functions that meet user and customer requirements, supports training and regulatory requests, and provides guidance to QC personnel.

Requirements

Bachelor’s degree in a specified or related science field and 5 or more years of experience; or a master’s degree in a specified or related science field and 3 or more years of related experience; or a Ph.D. in a specified or related science field and 0 or more years of related experience.
At least 5 years of project management experience.
1–3 years of experience in a GMP environment.
2–3 years of stability study management and protocol issuance experience.
Experience working with customers and in technology transfers.

Nice To Haves

At least 5 years of project management experience in biotechnology, pharmaceutical, CRO, or CLO settings.
Experience with Customer Relationship Management.
Drug substance or manufacturing experience, including process validation, transfer, commercialization, manufacturing support, and troubleshooting.
Experience using quality systems such as deviation management, change control, CAPA, or document management systems.

Responsibilities

Collaborate with customers and stakeholders from QC, Drug Substance Manufacturing, and Drug Product fill/finish to support technology transfers involving QC Sample Plans, stability studies, and DS/DP Specifications.
Author, review, and lead updates to controlled GMP documents related to QC Sample Plans, QC Specifications, stability protocols and reports, and stability specifications.
Lead, author, and review change controls for QC Sample Plans and stability protocols, coordinating with stakeholders and communicating with customers as applicable.
Manage and direct continuous improvement of QC Sample Plans and QC Specifications.
Identify and resolve technical compliance gaps and quality or process improvement needs, leading work through completion and sustainable implementation.
Lead or participate in team compliance activities, including writing, changing, and maintaining GMP documents with stakeholders and QA.
Ensure compliance with platforms, procedures, and the global QC vision.
Support management with training compliance and inspections.
Support regulatory requests, audits, and inspections.
Collaborate with the LIMS team and IT to build DS/DP sample-plan, specification, and stability functions that meet end-user and customer requirements.
Provide guidance and feedback to support QC personnel development.
Perform other duties as assigned.