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FUJIFILM Biotechnologies · 8 hours ago

Analyst, QC Microbiology

Holly Springs, NC

Full-time

Onsite

New Grad, Entry Level

0+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The QC Analyst is responsible for key operational aspects of the QC Microbiology laboratory, including performing microbial testing and managing associated activities in accordance with written procedures.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Collects samples for Environmental monitoring (EM) and Utilities monitoring (UM). Responsible for all sample collection and logistics as needed

Coordinates testing materials and supplies needed for testing

Performs Basic Microbiology laboratory testing following standard procedures for all samples, including but not limited to all in-process samples, raw materials, EM and utilities samples for Bioburden, Endotoxin, plate reading, and microbial identification

Performs sterility testing, isolator qualification and routine operations and maintenance

Sample and data entry into LIMS system

Reviews general lab testing results

Troubleshoots routine assays

General laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations, maintenance of analytical instruments, purchasing and receiving of laboratory supplies (media, kits, etc.)

Ensures CAPAs are being followed in the laboratory areas

Notifies management and assists with the initiation of events (such as deviations) in the quality systems

Assists with projects as assigned

Works 12-hour shift on 2-2-3 cadence, 0600-1800

Performs other duties as assigned

Qualification

Microbiology laboratory methodsGMP knowledgeLIMS systemBioburden testingEndotoxin testingSterility testingMicrobial ID systemsBasic GLP experienceTrackwise System trainingLean / 6S training

Required

BA/BS in scientific discipline

0-2 years of basic GLP laboratory experience

Understanding of GMP, GLP, GDP requirements

Knowledgeable in basic sciences and Microbiology laboratory methods and procedures

Basic LIMS training

Preferred

BS within Microbiology, Chemistry, Biochemistry, Biology

2+ years of Intermediate experience in a GMP QC Microbiology Laboratory, knowledge of all compendial test methods (Bioburden, Endotoxin, sterility testing) preferred

Ability to troubleshoot and maintain laboratory equipment and instrumentation

Experience with microbial ID systems (MALDI, MicroSeq)

Intermediate LIMS training

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

Trackwise System training

Lean / 6S training

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)