Quality Control Microbiology Technician

Perform microbiological and quality control testing in accordance with approved Standard Operating Procedures (SOPs), regulatory requirements, and established laboratory methods to support product quality, environmental monitoring, contamination control, and material release activities. Evaluate test results for compliance with company specifications, investigate and communicate out-of-specification or atypical results, and support microbiological assessments and trending activities.

Conduct incoming inspection and release of raw materials, components, consumables, and packaging materials used in the production and packaging of tissue products and medical devices. Verify materials meet established quality requirements through inspection, testing, and documentation review. Accurately document results, maintain compliance with Good Documentation Practices (GDP), and collaborate with cross-functional teams to support product release, regulatory compliance, and continuous improvement initiatives.

- Perform well-defined, standardized microbial tests on donor culture samples, environmental samples and related supplies:

- Microbiological identification of bacterial and fungal growth in/on both liquid and plate media; subculturing and identification of microorganisms to determine acceptability based on sample type

- Media suitability tests (i.e. growth promotion and sterility) to ensure incoming media (both liquid and plate media) used to grow bacteria/fungi are not contaminated and are able to sustain microbial growth

- Endotoxin testing on water system samples and final products

- Conduct physical inspections of raw materials (e.g. gowns, gloves, instruments, etc.) and finished goods (e.g. packaging, labels, marketing materials, etc.) received in the warehouse, per guidelines outlined in SOP's or material specifications

- Compare findings of test results to established guidelines; identify reasons for failure and retest as permitted; initiate investigation for any failed test (i.e. out-of-specification result)

- Assist in investigations, corrective actions/preventive actions (CAPA's), document changes, trending, etc. by providing requested information and implementing defined, corrective measures

- Perform preventive maintenance and equipment cleaning (e.g. incubators, refrigerators, carbon analyzers, etc.) used to perform quality control tests and/or in the manufacture of tissue products, as scheduled

- Bachelor's degree in microbiology or a Bachelor's degree in a science related field and microbiology certification (ASM, ASCP, NRCM, etc.)

- Minimum of 2 years of experience working within a microbiology laboratory

- Experience with microbiology related testing (e.g. general microbiological techniques, micro identification, bioburden, sterility, endotoxin, ELISA, environmental monitoring, etc.)

- Knowledge of AATB, FDA, and other state/federal/international regulations preferred

- Knowledge of USP, ISO, AAMI, ANSI, ASTM standards preferred

- Strong written, verbal, and interpersonal communication skills

- Highly organized, detail-driven, and able to manage multiple priorities

- Demonstrated ability to learn and apply new technical skills

- Work is performed in laboratory settings, controlled environments, warehouse, and office spaces

- Hands-on use of lab equipment and inspection tools is required

Reliable transportation is needed for travel between nearby facilities (~ 8 miles)