Quality Control Microbiologist

Duties And Responsibilities

• Perform Quality Control (QC) testing of tissue samples including, but not limited to, Cell Viability testing, bioburden of recovery cultures, sterility testing, in-process bioburden, method suitability, gram staining, biochemical testing, and microbial identification using VITEK 2.
• Perform QC release testing of microbiology media, materials, and reagents.
• Review test results and manage Biomaterial Tracking System (BTM) according to internal standard procedures to ensure proper management, tracking, and disposition of grafts.
• Communicate directly with outside laboratories (if needed) to obtain records and internally with Operations and Quality Assurance to ensure appropriate samples are available for testing and results are properly communicated.
• Maintain proper documentation and trend analysis of QC test results.
• Support environmental monitoring (EM) of the facility by reading environmental monitoring plates, processing samples for identification, maintain records and trend analysis.
• Support water system testing of the facility by testing for total organic carbon (TOC), bioburden, endotoxin, and conductivity. Reading plates and processing samples for identification.
• Perform laboratory cleaning and maintenance of equipment as needed.
• Support and execute qualification / validation protocols of QC testing methods as applicable.
• Review testing reports, protocols, and procedures to ensure compliance with internal requirements and applicable regulations.
• Aid in maintaining the laboratory stock of media and reagents and ordering laboratory supplies.
• Participate in the on-call weekend alternating schedule.

Requirements

• Education/Experience: Bachelor’s in Science, Microbiology degree preferred or Associate in Science with two years of experience. An equivalent combination of education and experience in a regulated environment (e.g., Biologics, Microbiology, Pharmaceutical, etc.) will be considered.
• Laboratory Skills: Aseptic techniques, bioburden, sterility, growth promotion, gram staining, microbial identification, and microbiology testing.
• Other Skills: Excellent interpersonal, verbal, and written communication skills required. Must demonstrate excellent organizational and record keeping skills. Must be detail oriented with the ability to multi-task in a high-pressure environment. Must gain knowledge of all regulations, laws, and/or standards that govern the tissue banking industry within the first year of employment.
• Computer and Equipment: Proficient in Microsoft Office. Working knowledge of Vitek® 2, Sievers M9 Laboratory TOC Analyzer, Conductivity Meter and Cell Analyzers.