QC Microbiologist II

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Aveva Drug Delivery Systems is seeking a QC Microbiologist II to perform microbiological testing across materials and products and maintain a GMP-compliant microbiology laboratory in Tamarac, FL. The role involves ensuring adherence to USP guidance, executing routine testing, and contributing to method development and audits.

The position requires a Bachelor's degree in microbiology (or equivalent) and 2–4 years of lab experience, with a Master's degree offering additional qualification.

Qualifications

• Bachelor's degree in microbiology or equivalent required.
• Master's degree in microbiology with 1–2 years lab experience preferred.
• Experience with FDA, cGMPs and SOPs related to microbiology duties.

Responsibilities

• Perform Microbial Limits and related assays on finished products, raw materials and components.
• Monitor bio-burden in facility and lab.
• Review USP guidelines and regulatory guidance for compliance.
• Test daily USP Purified Water System.
• Author/review protocols, reports, STPs, and SOPs.
• Support weekend/holiday testing as needed.
• Conduct trend analysis of microbiology results.

Skills

FDA compliance

cGMPs

SOPs

Education

Bachelor's degree in microbiology

Master's degree in microbiology

Job description

Job Details

Job Location: Tamarac, FL 33321

Job Summary

The QC Microbiologist II performs microbiological testing of raw materials, intermediate/finished products, and environmental bio-burden. He/She maintains a functional and current GMP compliant microbiology laboratory.

Job Responsibilities

• Perform Microbial Limits and Microbial Limits Validation assay of finished products, raw materials, and components in a timely manner.


• Perform bio-burden monitoring of the manufacturing facility and the microbiology laboratory.


• Review current USP and the regulatory guidance to ensure compliance with current microbiological methods and practices.


• Responsible for daily monitoring and testing of the USP Purified Water System.


• Author, and review of microbiology Protocols, Reports, STP's and SOP's.


• Responsible for microbiology testing for weekend and holiday schedules, as needed.


• Performs trend analysis of microbiology test results from products, water system, bio-burden and author reports.


• Perform IQ/OQ/PQ on instruments and author the protocols/reports.


• Attend seminars on special topics to continually evaluate improvements to the microbiology laboratory, testing, and policy.


• Required to participate in audits and/or consultations with other departments, as required.


• General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, bio hazard waste disposal, sample discard, discard of expired reagents, media preparation, sterilization of waste and glassware, instrument calibration/maintenance/daily monitoring, quarterly expenses report, and inventory/ordering.


• Works as a member of a team to achieve all outcomes


• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements


• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion


• All other relevant duties as assigned

Qualifications

• Education
  
  
  
  • Bachelor's degree (B. S.) in microbiology or equivalent
  
  
  
  


• Knowledge, Skills and Abilities
  
  
  
  • FDA, cGMPs, and SOPs related to job requirements.
  
  
  
  


• Experience
  
  
  
  • Minimum of 2-4 years laboratory experience.
  
  
  • Master's degree (M.S) in microbiology and a minimum of 1-2 years laboratory experience.