Vivex Biologics · 2 months ago
Quality Control Microbiologist II
Miami, FL
Full-time
Onsite
Mid Level
3+ years expVIVEX Biologics is a company focused on biological products, and they are seeking a Quality Control Microbiologist II. The role involves performing microbiological testing, managing results, and ensuring compliance with standard operating procedures and regulatory standards.
BiotechnologyHealth CareTherapeutics
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
Performs reviews and approval of routine testing documents
Responsible for reporting and analyzing 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
Lead QC validations and supports interdepartmental validations and qualifications that require microbiological testing
Support Write investigations, deviations, and change controls. Manages the implementation of controlled changes and corrective actions
Participate in the on-call weekend schedule
Perform other duties as assigned by QC Management
Qualification
Required
Bachelor's degree in science with at least 3-4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.)
Associate's degree in science with at least 4 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
Company
Vivex Biologics
VIVEX Biologics' mission is to provide regenerative product solutions that help patients suffering from musculoskeletal injuries and wounds.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chris Agle
President & COO Legacy Donor Services Foundation
Tim Ganey
Chief Science Officer
Recent News
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