Sr Associate I, Quality Control Microbiology

About the role

We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory.

Responsibilities

• Review test data in LIMS
• Prepare quarterly EM/UM reports
• Supports testing for all qualification and study directed testing
• Troubleshoot complex assays
• Perform microbiology testing (e.g. Bioburden, Endotoxin, plate reading, and microbial identification) following standard procedures
• Conduct routine Environmental Monitoring (viable and non-viable) in controlled manufacturing areas
• Collect and process utility and compressed gas samples
• Comply with SOPs and controlled documents under minimal supervision
• Maintain laboratory cleanliness, equipment readiness, and inventory
• Perform investigations (i.e. laboratory and deviations)
• Follow site safety and contamination control policies
• Work overtime as required by business needs
• Perform other assigned duties

Requirements

• Bachelor’s in Microbiology, Biology, or related field
• Minimum 4 years’ experience in pharmaceutical microbiology and GMP-regulated manufacturing
• LIMS experience, including using electronic notebooks
• Demonstrated knowledge of microbiological assays (bioburden, endotoxin, environmental monitoring), aseptic techniques, and general laboratory techniques
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Able to follow procedures and complete technical tasks
• Physically able to stand long periods, bend, move carts, and lift 25 lbs
• Strong written and verbal communication skills, along with proficiency in Microsoft Word and Excel
• Excellent organizational skills with the ability to prioritize, follow through on tasks, and meet deadlines

Preferred Skills

• Advanced knowledge of Microbiology testing and Microbiology theory
• Prior experience in utilities monitoring, including gas monitoring
• Prior training experience, including classroom training
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
• LEAN lab and Six Sigma training and/or certification
• Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
• Prior experience performing EM/UM excursion investigations