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FUJIFILM Biotechnologies · 1 hour ago

Sr Analyst 1, QC Microbiology

Holly Springs, NC

Full-time

Onsite

Mid, Senior Level

2+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory, performing microbial testing, and training team members while working independently with minimal supervision.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test

Leads sample collection and manages sample logistics for testing

Supports testing for all qualification and study directed testing

Supports investigation of routine OOS assays and events

Conducts qualification and validation protocols

Leads sterility testing

Reviews intermediate lab testing results

Troubleshoots complex assays

Writes and assists with document preparation and review

Manages project timelines

Assists management with training and on-boarding of new staff as needed

Embraces LEAN lab and six sigma principles and applies them to laboratory processes

Champions projects and project management as assigned

Performs other duties, as assigned

Qualification

Microbiology experienceGMP knowledgeMicrobiology testingLIMS experienceLEAN lab principlesSix Sigma certificationDocument controlStatistical toolsFDA regulations knowledgeTraining skills

Required

Bachelor's with 2+ years of relevant Microbiology experience OR

Master's with 0 years of experience

Experience with aseptic production & support

1-3 years in a GMP environment

Advanced understanding of GMP, GLP, GDP requirements

Advanced knowledge in Microbiology theory

Advanced knowledge of Microbiology testing and laboratory experience

LIMS experience

Experience with document control including reviewing and editing technical documents

LEAN lab and Six Sigma training and/or certification

Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results

Intermediate LIMS software training

Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)

Preferred

Master's with 1+ years of experience

4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage

Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)

Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)

Advanced LIMS / Trackwise software training

Experience working within a QC laboratory environment, commissioning Pharmaceutical and/or laboratory facilities

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)