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Company

FUJIFILM Diosynth Biotechnologies · 1 day ago

QC Analyst III, Cell Biology (On-site in College Station, TX)

United States

Full-time

Remote

Mid Level

3+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

Hiring Manager

Lisa Cramer, MBA

Insider Connection @FUJIFILM Diosynth Biotechnologies

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Responsibilities

Participate in training the QC Bioassay Staff at FDBT in the established release methods.

Perform QC analytical testing for GMP release and stability testing as needed.

Executes tech transfer, qualification and validation protocols as needed.

Contributes to writing and revising Standard Operating Procedures (SOPs), Technical Reports, and other Good Manufacturing Practices (GMP) documentation as appropriate.

Maintain data integrity and compliance with company SOPs and specifications, FDA, and cGMP regulations.

Participate in functions involving teams which impact timelines, improve quality and increase efficiency.

Complete all testing, including special project/protocol testing in a timely and appropriate manner.

Must communicate effectively (verbal and written) with supervisors and peers and be able to work cross-functionally with other groups.

Perform other duties as assigned.

Qualification

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Degree in scienceGMP/GxP experienceELISA methodsCell-based assaysMonoclonal antibody testingAssay troubleshootingGMP documentationCritical reagents qualificationData analysisComputer proficiency

Required

Bachelor’s degree in science related field with 3+ years of experience; OR

Associate’s degree in science related field with 5+ years of experience.

2+ years’ industry experience in a GMP/GxP or a comparable federally regulated environment.

Proficient in ELISA based methods, cell-based assays and qualification of critical reagents methodologies.

Ability to analyze raw data, assess assay and system suitability criteria.

Strong critical thinking, time management and organizational skills. Demonstrate the ability to multitask and consistently meet deadlines.

Ability to follow safety procedures outlined in the Chemical Hygiene Plan.

Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.

Excellent attention to detail.

Computer proficiency required.

Excellent written and oral communication skills.

Excellent organization and analytical skills.

Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Preferred

Degree in Biology preferred.

Familiar with monoclonal antibody testing methodology preferred.

Experience in assay troubleshooting and problem solving preferred.

Familiar with GMP documentation and Quality Systems.

Company

FUJIFILM Diosynth Biotechnologies

Glassdoor

3.4

Fujifilm Diosynth Biotechn, contract development & manufacturing provider for preclinical, clinical and commercial biologics manufacturing.

Founded in 2011

Morrisville, North Carolina, USA

1,001-5,000 employees

http://www.fujifilmdiosynth.com

H1B Sponsorship

FUJIFILM Diosynth 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

2022 (1)

2021 (1)