QC STAT Associate

Role Summary

QC STAT Associate located in Devens, MA, with night shift and 20% differential. Responsible for routine testing, data review, and supporting QC operations in a cGMP environment. Work involves analytical methods, documentation, and collaboration within QC and cross-functional teams.

Responsibilities

• Perform routine testing and data review of in-process and batch release samples of Bulk Drug Substance in a cGMP compliant environment.
• Perform routine assays such as UV-VIS Spectrometry, Titer, utility testing, personnel and environmental monitoring, Total Organic Carbon testing, and more complex assays including various HPLC methodologies (e.g., sialic acid).
• Support lab operations including housekeeping, alarm acknowledgement, reagent preparation, inventory management, material and reagent ordering, sample handling, and execution of work orders.
• Understand and follow procedures in a fast-paced team environment, meet deadlines, and adapt to changing priorities.
• May write and revise QC documents for managerial review and approval.
• May train colleagues on basic and some more complex test methods.
• Support deviation investigations and laboratory investigations; may lead no-impact deviations and Lab Investigations.
• Identify and escalate challenges, suggest solutions, and participate in remediation with troubleshooting support.
• Engage in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives within the team.
• Collaborate within QC and with cross-functional teams; model company values in all tasks.
• Complete all required tasks compliantly and safely, following procedures and timelines.

Qualifications

• High school diploma/GED or equivalent with direct relevant experience (≥15 years).
• Associate's degree in a technical, scientific discipline with ≥9 years' experience.
• Bachelor's Degree in a non-technical discipline with ≥5 years' experience.
• Bachelor's degree in a Scientific relevant area with ≥1 year(s) experience.
• Master's degree in a Scientific relevant area.
• Equivalent combination of education and experience, preferably in a regulated environment.
• Experience in analytical test methods such as UV/Vis, HPLC, TOC, and protein purification is highly preferred.
• Knowledge of lab software applications (e.g., LIMS, ELN, Empower) preferred.
• Excellent manual dexterity with aseptic techniques desired.
• High attention to detail with strong laboratory and organizational skills.
• Ability to work independently and in a team; meet defined time constraints.
• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
• Demonstrated problem solving and analytical thinking skills.