Microbiologist III

Responsibilities

• Lead and/or support quality event investigations for out-of-specification (OOS), out-of-trend (OOT) or nonconformance events
• Perform environmental monitoring of clean rooms (under ISO and EU specifications)
• Perform and review QC testing (Endotoxin, Bioburden, TOC, Conductivity, Growth Promotion Assay, etc.) for manufacturing, raw materials, in-process materials, intermediates and final product
• Demonstrate technical proficiency in test procedures and ensure QC activities are carried out using applicable regulatory requirements (FDA, USP, ICH etc.)
• Participate in audits, client investigations, and project-related activities
• Lead and/or support activities associated with Change Control, CAPAs, client audit response, work orders, etc.
• Receive and process samples to meet production/client timelines
• Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results
• Prepare and send out samples for microbiological identification
• Ensure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are met
• Work closely and collaborate in a team environment with QC Analytical and Quality Assurance, Manufacturing, Technical Services, Materials Receiving, and Research and Development
• Support Manufacturing with client-specific testing requirements
• Inspection of media fills

Qualifications

• Bachelor’s Degree in Microbiology or related field
• Minimum 5+ years’ industry experience in a GMP sterile finish or pharmaceutical cleanroom environment
• Willing to work flexible hours (nights and weekends), as-needed
• Knowledge of FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
• Knowledge of USP, , , and
• Attention to details and following GMP methods and instructions