Analyst, All QC (Night Shift: 6 p.m. to 6 a.m.)

About the role

The Analyst, 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.

What You'll Do

• 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
• Supports environmental and utilities monitoring sample collection
• Provides input to define protocols for sample collection and logistics, ensuring compliance with regulatory standards
• Coordinates testing materials and supplies
• Plans and ensures materials are stocked. Partners with procurement, inventory management, and distribution to optimize laboratory operations
• Ensures accuracy and security of laboratory information, implementing tools and protocols for data management
• Conducts comprehensive reviews of laboratory testing results and provides analysis and interpretation of results, identifying trends and making informed recommendations
• Under the direction of management, troubleshoots issues with laboratory assays and identifies underlying causes of assay failures and develops strategic solutions to improve test reliability
• Leads general laboratory support and maintenance initiatives by maintaining analytical instruments and laboratory resources, coordinating purchases and receipt of essential supplies
• Supports implementation and monitoring of CAPAs
• Partners with management to initiate and coordinate resolution for deviations and non-conformance events within quality systems
• Participates in project developments from concept through execution, ensuring alignment with organizational goals
• Performs additional duties, as needed

Minimum Requirements

• Bachelor's degree in scientific discipline with 0-1 years of experience
• Basic understanding of GMP, GLP, GDP requirements

Preferred Requirements

• 2+ years of Intermediate experience in a GMP QC Laboratory, knowledge of all compendial test methods preferred
• Ability to troubleshoot and maintain laboratory equipment and instrumentation

Physical and Work Environment Requirement

• Will work in environment operating a motor vehicle or Powered Industrial Truck
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color