Quality Control Microbiologist

4 weeks ago

Miami, United States VIVEX BIOLOGICS INC Full time
Job DescriptionJob DescriptionDescription:

Job purpose


The Quality Control Microbiologist (QCM) is responsible for performing and managing quality control testing results for human tissue donors, recovered, and acquired tissue, and final processed grafts. Must perform applicable QC testing and related functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements. Communicates directly with contracted laboratories and internal departments to ensure testing results are available, accurate and communicated in a timely manner.


Duties and responsibilities


  1. 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.
  2. Perform QC release testing of microbiology media, materials, and reagents.
  3. Review test results and manage Biomaterial Tracking System (BTM) according to internal standard procedures to ensure proper management, tracking, and disposition of grafts.
  4. Communicates 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.
  5. Maintain proper documentation and trend analysis of QC test results.
  6. Support environmental monitoring (EM) of the facility by reading environmental monitoring plates, processing samples for identification, maintain records and trend analysis.
  7. 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.
  8. Perform laboratory cleaning and maintenance of equipment as needed.
  9. Support and execute qualification / validation protocols of QC testing methods as applicable.
  10. Review testing reports, protocols, and procedures to ensure compliance with internal requirements and applicable regulations.
  11. Assist Manager in maintaining the laboratory stock of media and reagents and ordering laboratory supplies.
  12. Participate in the on-call weekend alternating schedule.

General Responsibilities

  1. Create, review, and edit QC procedures according to AATB, FDA and USP guidelines.
  2. Maintain knowledge of appropriate federal and state regulatory and statutory requirements as well as accrediting body requirements.
  3. Responsible for reporting all variances, errors, and deviations to QA management.
  4. Participate in the investigation complaints and deviations including the formulation and implementation of corrective actions.
  5. Participate in audits and inspections, as needed.
  6. Maintain trend analysis and metrics of testing results.
  7. Support accreditation and licensing activities.
  8. Perform other duties as assigned by the QC Manager and/or Director of Quality Control.


Requirements:

Qualifications


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.



Working conditions


Primarily, a fast pace, lab-oriented work environment. Evening and weekend work may be required.


Physical requirements


While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.


Direct Reports

No direct reports.


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