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Microbiologist for Quality Assurance

2 months ago

Miami, Florida, United States VIVEX BIOLOGICS INC Full time
Job Overview

Position Summary

The Quality Control Microbiologist is tasked with overseeing and executing quality assurance testing for human tissue donors, recovered tissues, and processed grafts. This role necessitates adherence to established standard operating procedures and compliance with all relevant federal and state regulations. The Microbiologist will liaise with both external laboratories and internal teams to guarantee that testing outcomes are accurate and promptly communicated.

Key Responsibilities

  1. Conduct Quality Control (QC) assessments on tissue samples, including but not limited to, Cell Viability assessments, bioburden cultures, sterility evaluations, in-process bioburden checks, method suitability tests, gram staining, biochemical analyses, and microbial identification using VITEK 2.
  2. Perform QC release evaluations on microbiological media, materials, and reagents.
  3. Analyze test results and manage the Biomaterial Tracking System (BTM) in line with internal protocols to ensure effective management, tracking, and disposition of grafts.
  4. Engage with external laboratories as necessary to retrieve records and collaborate with Operations and Quality Assurance to ensure that appropriate samples are available for testing and results are effectively communicated.
  5. Maintain comprehensive documentation and conduct trend analysis of QC test results.
  6. Assist in environmental monitoring (EM) by reviewing environmental monitoring plates, processing samples for identification, and maintaining records and trend analysis.
  7. Support water system evaluations by testing for total organic carbon (TOC), bioburden, endotoxin, and conductivity, along with reading plates and processing samples for identification.
  8. Carry out laboratory cleaning and equipment maintenance as required.
  9. Support and implement qualification/validation protocols for QC testing methods as applicable.
  10. Review testing reports, protocols, and procedures to ensure adherence to internal standards and applicable regulations.
  11. Assist the Manager in maintaining laboratory inventory of media and reagents and ordering necessary supplies.
  12. Participate in an alternating on-call weekend schedule.

General Duties

  1. Develop, review, and revise QC procedures in accordance with AATB, FDA, and USP guidelines.
  2. Stay informed about relevant federal and state regulatory requirements as well as standards set by accrediting bodies.
  3. Report all variances, errors, and deviations to Quality Assurance management.
  4. Contribute to the investigation of complaints and deviations, including the development and implementation of corrective actions.
  5. Participate in audits and inspections as required.
  6. Maintain trend analysis and metrics of testing outcomes.
  7. Support accreditation and licensing processes.
  8. Perform additional duties as assigned by the QC Manager or Director of Quality Control.

Qualifications

Education and Experience: A Bachelor’s degree in Science, preferably in Microbiology, or an Associate degree in Science with two years of relevant experience. An equivalent combination of education and experience in a regulated environment (e.g., Biologics, Microbiology, Pharmaceutical) will be considered.

Laboratory Skills: Proficiency in aseptic techniques, bioburden testing, sterility assessments, growth promotion, gram staining, microbial identification, and microbiological testing.

Other Skills: Strong interpersonal, verbal, and written communication skills are essential. Must exhibit excellent organizational abilities and meticulous record-keeping skills. Attention to detail and the capacity to manage multiple tasks in a high-pressure environment are crucial. Must acquire knowledge of all regulations, laws, and standards governing the tissue banking industry within the first year of employment.

Technical Proficiency: Competence in Microsoft Office is required. Familiarity with Vitek 2, Sievers M9 Laboratory TOC Analyzer, Conductivity Meter, and Cell Analyzers is beneficial.

Work Environment: The position primarily involves a fast-paced, laboratory-oriented work setting. Evening and weekend work may be necessary.

Physical Requirements: The employee is regularly required to sit or stand for extended periods. Occasionally, the employee may need to pull, lift, or move up to 20 pounds.

Direct Reports: This position does not have any direct reports.