QC Analyst III, Microbiology Specialist

1 day ago

College Station, Texas, United States FUJIFILM Corporation Full time
Job Title: QC Analyst III, Microbiology

Job Summary:

FUJIFILM Diosynth Biotechnologies Texas (FDBT) is seeking a highly skilled QC Analyst III, Microbiology to join our Quality Control Laboratory team. As a key member of our team, you will be responsible for ensuring the quality and safety of our products through microbiological testing and compliance with cGMP regulations.

Responsibilities:

  • Perform microbiological verifications for finished product and in-process controls and buffers.
  • Qualify microbiological media, diluents, and organisms.
  • Qualify APS media and inspect for turbidity.
  • Conduct Biological Indicator Testing and qualification activities.
  • Perform Material Bioburden Testing and Bioburden Suitability.
  • Conduct Bacterial Endotoxin Testing and Inhibition/Enhancement Testing for Product Samples and Buffers.
  • Identify bacteria using the Biology method and fungi using Macroscopic Identification.
  • Conduct Sub-Visible particulate Testing by USP , , and , Method 1 and Method 2.
  • Participate in the investigation and review of alert and action limit investigations as needed and implement 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 EM and product release data.
  • Ensure the laboratory is maintained (organized, clean, properly supplied).

Qualifications:

  • Bachelor's degree in Biochemistry, Chemistry, Biology, or related field with 2+ years of relevant GMP experience; OR
  • Associate of Science 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.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged standing, some bending, stooping, and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
  • Ability to sit for long periods to work on a computer.
  • Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
  • Ability to lift/pull/push 50 lbs on occasion and 15 lbs regularly.
  • Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
  • Attendance is mandatory.

About FUJIFILM Diosynth Biotechnologies Texas:

FUJIFILM Diosynth Biotechnologies Texas (FDBT) is a leading biotechnology company that specializes in the development and manufacturing of biopharmaceuticals. We are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

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