QC Analyst III, Microbiology

FUJIFILM Biotechnologies; College Station (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a qualified QC Analyst III specializing in Microbiology to oversee critical microbiological quality control tasks in compliance with cGMP standards. The position requires attention to detail, strong technical skills in aseptic techniques, and a commitment to maintaining high safety and quality standards. This role offers opportunities to work in a vibrant biotechnology environment focused on innovation and excellence.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

Qualifications

• Minimum 2 years of relevant GMP experience with a Bachelor's degree.
• At least 3 years of GMP experience with an Associate's degree.
• 4 years of relevant experience with a High School Diploma or GED.

Responsibilities

• Responsible for QC microbiological aspects of cGMP compliance and testing.
• Perform microbiological verifications and Bacterial Endotoxin Testing.
• Develop and revise microbiological Standard Operating Procedures (SOPs).

Skills

Aseptic technique

Analytical skills

Problem solving

Leadership

Education

Bachelor’s degree in Biochemistry, Chemistry, Biology, or related field

Associate of Science in Biochemistry, Chemistry, Biology, or related field

High School Diploma or GED

Job description

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Join to apply for the QC Analyst III, Microbiology role at FUJIFILM Biotechnologies

Direct message the job poster from FUJIFILM Biotechnologies

Senior Recruiter for FUJIFILM Diosynth Biotechnologies (through NXTThing RPO)

Position Overview

The Microbiology III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Diosynth Biotechnologies Texas (FDBT) Quality Control Laboratory.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Job Description

Essential Functions:

• 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
• 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)
• Perform other duties as assigned.

Required Skills & Abilities:

• 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.
• Demonstrated written and oral communication skills.
• Demonstrated leadership skills.
• Strong organization and analytical skills.

Minimum Qualifications:

• Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with two (2) years of relevant GMP experience; OR
• Associate of Science preferably in Biochemistry, Chemistry, Biology, or related field with three (3) years of relevant experience; OR
• High School Diploma or GED with four (4) years of relevant experience;
• AND at least one (1) year of previous GMP experience.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

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