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FUJIFILM Biotechnologies · 8 hours ago

Senior Specialist 2, Quality Control Technical Transfer and Sample Support

Holly Springs, NC

Contract

Onsite

Senior Level

5+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Sr. Specialist 2, QC Program Management Technical Transfer and Sample Support provides technical support through effective project management of QC Sample Plans and Specifications, collaborating with stakeholders to ensure compliance and support project milestones.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

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

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

Qualification

GMP ComplianceProject ManagementTechnical WritingQuality SystemsCustomer Relationship ManagementAttention to DetailVerbal CommunicationWritten CommunicationProblem SolvingTeam CollaborationMentoringFlexibility

Required

Bachelors in Biological Sciences, Engineering, or related science field with 5+ years of relevant experience OR

Masters in Biological Sciences, Engineering, or related science field with 3+ years of relevant experience

Prior experience of project management experience preferably 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

Excellent attention to detail. Leads improvement projects

Excellent verbal and written communication skills. Ability to analyze and present data and technical information to others outside of the team

Ability to develop and assign tasks develop structured plans

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 zeal for enhancing customer satisfaction

Self-driven, dedicated, and systematic and can plan your day and lead planning for others in a structured way

Flexible, has a positive attitude, positive energy and seeks challenges and opportunities and interested in developing yourself and the team

Ability to work cross-functionally with a diverse team and represent the department

Initiator, motivator, mentor for entire team

Preferred

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 leading project improvement management

LEAN/6S certification

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (1)