QC Microbiologist II

Aveva Drug Delivery Systems; Fort Lauderdale (FL); On-site; USD 60,000 - 80,000; Full time

Job summary

Aveva Drug Delivery Systems is seeking a QC Microbiologist II to perform microbiological testing on raw materials, intermediates, and finished products, ensuring GMP-compliant lab operations in Fort Lauderdale, FL.

The role requires a BS in microbiology (MS preferred) with 2–4 years of lab experience, familiarity with FDA/cGMPs, and proficiency in SOPs. Weekend/holiday coverage may be needed.

Qualifications

• Bachelor's degree in microbiology or equivalent.
• 2–4 years laboratory experience (Bachelor) or 1–2 years with a Master's.
• Familiarity with FDA, cGMPs, and SOPs.

Responsibilities

• Perform microbial limits testing on finished products, raw materials, and components.
• Monitor bio-burden in the manufacturing facility and microbiology lab.
• Review USP guidance and ensure compliance with microbiological methods.

Skills

Quality control

Microbiological testing

GMP compliance

FDA knowledge

SOP understanding

Education

Bachelor's degree in microbiology

Master's degree in microbiology

Job description

Description

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

Job Requirements

• 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.