QC Microbiologist

Key Duties and Responsibilities

The core duties of a QC Microbiologist include microbiology operations, focusing on the thorough identification of organisms, as well as conducting tests for:

• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
• Preservative Efficacy Testing (PET)
• Sterility and Endotoxin testing
• Sample analysis reporting

Conduct regular microbiology tests on finished products to verify compliance with specifications for TAMC, TYMC, and PET.

Develop and validate microbiology methodologies for testing manufactured products to meet specifications, ensuring compliance with pharmacopeial standards.

Identify microbes using techniques such as Gram stain and API kits.

Test environmental monitoring samples, qualify microbiological laboratory equipment, and provide sampling expertise.

The role includes routine and project activities, including implementing new laboratory systems.

Ensure the manufacturing environment conforms to GMP requirements, including environmental and personnel microbiological monitoring, plate reading, and follow-up on out-of-spec results.

Document all microbiological activities accurately and clearly.

Report microbiological results precisely, assist in investigations, and produce reports per SOP.

Maintain calibration and validation of microbiological equipment.

Write reports, SOPs, and other documentation as needed.

Support QC in performing analytical testing of raw materials and finished products using equipment like HPLC and UV.

Perform any other duties as required.

Essential Experience, Skills, and Abilities

Relevant Microbiology degree and experience in a microbiology laboratory.

Strong knowledge of microbiological testing techniques, including water testing, microbial limit testing, and microbial identification.

Understanding and application of GMP guidelines and regulations.

Ability to work methodically and meet tight deadlines.

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