Senior Analyst 1, QC Microbiology

About the role

The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The role involves performing and training other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role also supports testing for all qualification and study directed testing, investigates routine OOS assays and events, conducts qualification and validation protocols, reviews intermediate lab testing results, troubleshoots complex assays, writes and assists with document preparation and review, manages project timelines, and assists management with training and on-boarding of new staff as needed.

Responsibilities

• Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test
• Supports testing for all qualification and study directed testing
• Supports investigation of routine OOS assays and events
• Conducts qualification and validation protocols
• Leads sterility testing
• Reviews intermediate lab testing results
• Troubleshoots complex assays
• Writes and assists with document preparation and review
• Manages project timelines
• Affords assistance with training and on-boarding of new staff as needed
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes
• Champions projects and project management as assigned
• Performs other duties, as assigned

Requirements

• Bachelor’s with 2+ years of relevant Microbiology experience OR Master’s with 0 years of experience
• Experience with aseptic production & support 1-3 years in a GMP environment
• Advanced understanding of GMP, GLP, GDP requirements
• Advanced knowledge in Microbiology theory
• Advanced knowledge of Microbiology testing and laboratory experience
• LIMS experience
• Experience with document control including reviewing and editing technical documents
• LEAN lab and Six Sigma training and/or certification
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Intermediate LIMS software training
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)

Qualifications

• Bachelor’s degree in Microbiology or related field
• Master’s degree in Microbiology or related field
• 2+ years of relevant Microbiology experience
• 1-3 years of experience in a GMP environment
• Advanced understanding of GMP, GLP, GDP requirements
• Advanced knowledge in Microbiology theory
• Advanced knowledge of Microbiology testing and laboratory experience
• LIMS experience
• Experience with document control including reviewing and editing technical documents
• LEAN lab and Six Sigma training and/or certification
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Intermediate LIMS software training
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)