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FUJIFILM Biotechnologies · 11 hours ago

Senior Specialist 1, Quality Control Tech Transfer & Sample Support

Holly Springs, NC

Contract

Onsite

Mid, Senior Level

2+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Senior Specialist 1, Quality Control Technical Transfer and Sample Support provides technical support and project management for QC Sample Plans and Specifications, collaborating with stakeholders and ensuring compliance with regulatory guidelines.

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

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

Qualification

GMP ComplianceProject ManagementTechnical WritingQuality SystemsLEAN/6S CertificationBiological SciencesAnalytical SkillsCustomer Relationship ManagementCommunication SkillsTeam Collaboration

Required

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

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

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

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

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)