Senior Analyst 1, QC Testing (2-2-3 Shift)

About the role

The Sr. Analyst 1, Quality Control (QC) All QC Team is responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC.

Responsibilities

• Performs basic testing that spans all of the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
• 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
• Led sample collection and manages sample logistics for testing
• Supports testing for all qualification and study directed testing
• Supports investigation of routine OOS assays and events
• Reviews intermediate lab testing results
• Troubleshoots complex assays
• Writes and assists with document preparation and review
• Manages project timelines
• Aids management 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

Qualifications

• Bachelor’s with 2+ years of relevant QC 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 of QC testing and laboratory experience
• LIMS experience
• Experience with document control including reviewing and editing technical documents