Quality Control Microbiologist

VIVEX BIOLOGICS GROUP INC & SUBSIDIARIES • Miami, FL

9d

About The Position

The Quality Control Microbiologist (QCM) performs and manages quality control testing of human tissue donors, recovered and acquired tissue, and final processed grafts. The role carries out applicable testing and related functions under standard operating procedures and applicable federal and state regulations and accrediting standards. It communicates with contracted laboratories and internal departments to ensure that testing results are available, accurate, and communicated promptly.

The position also supports facility environmental monitoring and water system testing, maintains laboratory documentation and trend analyses, performs laboratory cleaning and equipment maintenance, and helps qualify or validate QC testing methods. It reviews testing reports, protocols, and procedures for compliance and assists with laboratory inventory and supply ordering. The role participates in an alternating weekend on-call schedule, audits and inspections, investigations, and accreditation and licensing activities. It has no direct reports.

Requirements

• Bachelor’s degree in Science; a Microbiology degree is preferred, or an Associate in Science degree with two years of experience.
• An equivalent combination of education and experience in a regulated environment, such as biologics, microbiology, or pharmaceuticals, will be considered.
• Laboratory skills in aseptic techniques, bioburden, sterility, growth promotion, gram staining, microbial identification, and microbiology testing.
• Excellent interpersonal, verbal, and written communication skills.
• Excellent organizational and record-keeping skills.
• Detail-oriented, with the ability to multitask in a high-pressure environment.
• Must gain knowledge of regulations, laws, and standards governing the tissue banking industry within the first year of employment.
• Proficiency in Microsoft Office.
• Working knowledge of Vitek 2, Sievers M9 Laboratory TOC Analyzer, conductivity meter, and cell analyzers.

Nice To Haves

• Microbiology degree.

Responsibilities

• Perform QC testing of tissue samples, including cell viability, recovery-culture bioburden, sterility, 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 the Biomaterial Tracking System (BTM) in accordance with internal procedures to ensure proper graft management, tracking, and disposition.
• Communicate with outside laboratories, as needed, to obtain records, and coordinate internally with Operations and Quality Assurance to ensure samples are available and results are communicated appropriately.
• Maintain documentation and trend analyses of QC test results.
• Support facility environmental monitoring by reading monitoring plates, processing samples for identification, and maintaining records and trend analyses.
• Support facility water system testing, including testing for total organic carbon (TOC), bioburden, endotoxin, and conductivity, and reading plates and processing samples for identification.
• Perform laboratory cleaning and equipment maintenance as needed.
• Support and execute qualification and validation protocols for QC testing methods, as applicable.
• Review testing reports, protocols, and procedures for compliance with internal requirements and applicable regulations.
• Assist the Manager with laboratory media and reagent stock and ordering laboratory supplies.
• Participate in the alternating weekend on-call schedule.
• Create, review, and edit QC procedures according to AATB, FDA, and USP guidelines.
• Maintain knowledge of applicable federal and state regulatory and statutory requirements and accrediting-body requirements.
• Report variances, errors, and deviations to QA management.
• Participate in complaint and deviation investigations, including formulating and implementing corrective actions.
• Participate in audits and inspections as needed.
• Maintain trend analyses and metrics for testing results.
• Support accreditation and licensing activities.
• Perform other duties as assigned by the QC Manager and/or Director of Quality Control.

What This Job Offers

• Job Type: Full-time