QC Microbiologist II

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 65,000 - 90,000; Full time

Job summary

Aveva Drug Delivery Systems Inc. seeks a QC Microbiologist II to perform microbiological testing of materials and products, monitor water systems, and ensure GMP compliance. You will author protocols, trend test results, and support audits. Strong documentation skills and knowledge of USP guidelines are essential. Weekend/holiday coverage may be required as part of a collaborative team.

Qualifications

• Bachelor's degree in Microbiology or equivalent required.
• 2–4 years lab experience; MS with 1–2 years acceptable.

Responsibilities

• Perform microbial limits testing on finished products, raw materials, and components.
• Monitor USP Purified Water System and bio-burden in the facility.
• Review USP and regulatory guidance to ensure current microbiological methods.
• Prepare and review microbiology protocols, reports, and SOPs.
• Conduct audits and participate in cross-departmental consultations as needed.
• Perform trend analysis of microbiology results and prepare reports.

Skills

Microbiology

GMP

Environmental monitoring

Documentation

Education

Bachelor's degree in Microbiology

Master's degree in Microbiology

Tools

IQ/OQ/PQ protocols

Job 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 assignedJob Requirements• Educationo Bachelor's degree (B. S.) in microbiology or equivalent• Knowledge, Skills and Abilitieso FDA, cGMPs, and SOPs related to job requirements.• Experienceo Minimum of 2-4 years laboratory experience.o Master's degree (M.S) in microbiology and a minimum of 1-2 years laboratory experience.