Quality Control Microbiologist I

VIVEX BIOLOGICS INC•Miami, FL

1d•Onsite

About The Position

The Quality Control Microbiologist I is responsible for performing microbiological testing and managing results of incoming raw materials, in-process samples, and final product samples. Review and analyze testing data to ensure internal specifications are met in accordance with standard operating procedures requirements. Ensure testing results are accurate, and results are available in a timely manner. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements.

Requirements

Bachelor’s degree in science with at least 0-2 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.).
Associate’s degree in science with at least 2 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.).
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.
Proficient in Microsoft Office.

Nice To Haves

Hands on Environmental Monitoring experience in a regulated GMP environment (cleanroom EM, viable/non-viable monitoring, trend analysis, excursions).

Responsibilities

Perform microbiology testing including, but not limited to reading of cultures, gram staining, microbial limit test, cell count and cell viability testing, growth promotion testing, and biochemical testing.
Support the environmental monitoring program (EM), Stability Program, and the Dose Audit Program.
Perform microbial characterization including subcultures of samples, gram stain, biochemical testing, and final identification using VITEK 2.
Conduct testing of clean utilities of the facility, including but not limited to performing TOC, pH, and conductivity testing.
Review and analyze test results according to internal standard procedures to ensure proper management, tracking, and disposition of materials and products
Responsible for reporting all variances, errors, and deviations to Quality Management.
Maintain proper documentation and trend analysis of QC test results.
Perform laboratory cleaning and maintenance of equipment.
Maintains the laboratory stock of media, reagents and laboratory supplies.
Support validations and qualifications that require microbiological testing.
Participate in audits and inspections, accreditation, and licensing activities as needed.
Supports investigations, complaints, and deviations contributing to the formulation and implementation of corrective actions.
Participate in the on-call weekend schedule.
Perform other duties as assigned by QC Management.