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FUJIFILM Biotechnologies · 9 hours ago

Senior Analyst 1, QC Raw Materials

Holly Springs, NC

Full-time

Onsite

Mid, Senior Level

1+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Senior Analyst 1, QC Raw Materials is responsible for GMP compliant laboratory operations and will participate in the Technology Transfer of established methods while performing raw material testing and disposition using established analytical methods.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.)

Supports QC Raw Materials team on internal tech transfer meetings related to new products

Under supervision and support, authors and reviews procedures, protocols, reports and specifications related to the raw material area

Performs testing and disposition of incoming raw materials and components according to specifications and procedures

Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs

Responsible for initiation and execution of Trackwise deviations, CAPA's, lab exceptions and invalid assays

Authors and implements corrective and preventative actions from approved deviations, CAPA's, lab exceptions and invalid assays in Trackwise

Performs routine investigations in support of out of specification testing results

Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results

Enforces established policies and procedures and escalates to management areas where enhancements will improve daily work

Assists Manager, QC in the implementation of new technologies

Adheres to pre ‐ defined turnaround times of raw material testing

Reviews new and updated specifications

Assesses lab exceptions and performs routine investigations

Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated

Performs other duties, as assigned

Qualification

GMP complianceRaw material testingAnalytical methodsTrackwiseAssay troubleshootingBachelor's in ScienceComputer proficiencySoft skills

Required

Bachelor's Degree degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline

1 ‐ 3 years relevant experience

Previous experience in a GMP environment

Computer proficiency required

Preferred

Masters degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years' experience

Familiar with Raw Material methodology as it pertains to cGMP

Experience in assay troubleshooting and problem solving

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)