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Company

FUJIFILM Diosynth Biotechnologies · 1 day ago

QC Microbiologist III (On-site in College Station, TX)

United States

Full-time

Remote

Mid Level

4+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

Hiring Manager

Lisa Cramer, MBA

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Responsibilities

Responsible for QC microbiological aspects of cGMP compliance and testing.

Perform microbiological verifications as needed for finished product and in process controls and buffers.

Qualification of microbiological media, diluents, and organisms.

Qualification of APS media and inspection for turbidity.

Biological Indicator Testing and qualification activities.

Material Bioburden Testing and Bioburden Suitability.

Bacterial Endotoxin Testing and Inhibition/Enhancement Testing for Product Samples and Buffers.

Bacterial Identifications using the Biology and Fungal Identifications by the Macroscopic Identification method.

Sub-Visible particulate Testing by USP <787>, <788> and <789>, Method 1 and Method 2.

Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.

Participate in the investigation of microbiological data deviations and PRs.

Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation.

Review of EM and product release data.

Ensure lab is maintained (organized, clean, properly supplied).

Qualification

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CGMP complianceMicrobiological testingAseptic techniqueBioburden TestingBacterial Endotoxin TestingData analysisChemical safety proceduresComputer skills

Required

Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with 2+ years of relevant GMP experience; OR

Associate of Science preferably in Biochemistry, Chemistry, Biology, or related field with 3+ years of relevant experience; OR

High School Diploma or GED with 4+ years of relevant experience;

AND 1+ year of previous GMP experience.

Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials.

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

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.

Good attention to detail and ability to utilize problem solving/trouble shooting skills.

Good computer skills.

Work under minimal supervision.

Demonstrated written and oral communication skills.

Demonstrated leadership skills.

Strong organization and analytical skills.

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

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)

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2022 (1)

2021 (1)