Microbiologist I

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 52,000 - 76,000; Full time

Job summary

Aveva Drug Delivery Systems Inc. in Florida is seeking a QC Microbiologist to perform microbiological testing of raw materials, intermediates and finished products, and to conduct environmental monitoring.

You will review USP guidance to ensure current methods and practices meet regulatory standards. The role requires a BS in microbiology (or equivalent), knowledge of FDA/cGMPs and SOPs, and 0–2 years of lab experience.

Qualifications

• Bachelor's degree in microbiology or equivalent.
• Knowledge of FDA regulations, cGMPs, and SOPs related to job requirements.
• 0–2 years laboratory experience.

Responsibilities

• Perform microbial testing of finished products, raw materials, and components in a timely manner.
• Perform environmental monitoring of the manufacturing facility.
• Review current USP and regulatory guidance to ensure compliant microbiological methods.
• Responsible for daily monitoring and testing of water systems and related utilities.
• Author and review microbiology protocols, reports, STPs and SOPs.
• Participate in audits and support cross-departmental collaborations.
• Maintain housekeeping, waste disposal, media/reagent inventory, calibration, and procurement.

Skills

FDA knowledge

cGMPs

SOPs

Education

Bachelor's degree in microbiology

Job description

Job Summary:The QC Microbiologist | performs microbiological testing of raw materials, intermediate/finished products, and environmental monitoring. He/She maintains a functional and current GMP compliant microbiology laboratory.Job ResponsibilitiesPerform microbial testing of finished products, raw materials, and components in a timely manner.Perform environmental monitoring of the manufacturing facility.Review current USP and the regulatory guidance to ensure compliance with current microbiological methods and practices.Responsible for daily monitoring and testing of the Purified Water System, and WFI 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, environmental monitoring, and author reports.Required to participate in audits and/or consultations with other departments, as required.General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, biohazard waste disposal, sample discard, discard of expired media and reagents, instrument calibration/maintenance/daily monitoring, 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.Job RequirementsEducationBachelor's degree (B.S.) in microbiology or equivalent.Knowledge, Skills and AbilitiesFDA, cGMPs, and SOPs related to job requirements.ExperienceMinimum of 0-2 years of laboratory experience.