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Position: QC STAT Associate

Location: Devens, MA

Night shift (5pm-5am rotational A2 and B2 schedules) therefore elegible for a 20% shift differential

Key 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 & Experience:

• 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.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.