QC STAT Associate

Role Summary

QC STAT Associate

Location: Devens, MA

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).
• Perform activities to support lab operations such as housekeeping, alarm acknowledgement, reagent preparation, inventory management, material and reagent ordering, sample pickup and discarding, and execution of work orders.
• Ability to understand and follow procedures while working in a fast-paced team environment, meet deadlines, and adjust 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.
• Supports deviation investigations and laboratory investigations through data gathering or interview process. May lead no impact deviations and Lab Investigations.
• Identifies and escalates challenges & barriers to execution, suggests solutions, and participates in remediation while assisting with a broad range of troubleshooting activities.
• Actively and positively learns and participates in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team.
• Positive, supportive, and actively collaborates within the team and other sub-teams within QC or cross-functionally outside of QC.
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).
• Ability to understand and follow procedures while working in a fast-paced team environment, meet deadlines, and adjust to changing priorities.

Qualifications

• High school diploma/GED or equivalent with some direct relevant experience (≥15 year).
• 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 years' experience.
• Master's degree in a scientific relevant area.
• An equivalent combination of education and experience, preferably in a regulated environment will be considered.
• Experience in analytical test methods such as UV/Vis, HPLC, TOC, and protein purification highly preferred.
• Knowledge of lab software applications (e.g., LIMS, ELN (LES/SmartLab), Empower) preferred.
• Excellent manual dexterity including proficiency in aseptic techniques desired.
• High attention to detail with strong general laboratory and good organizational skills.
• Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
• Demonstrates problem solving and analytical thinking skills.

Skills

• Analytical testing
• Laboratory operations
• cGMP compliance
• HPLC, UV/Vis, TOC
• Documentation and data review
• Team collaboration and training
• Problem-solving and continuous improvement