QC Associate

Position Overview

The Associate role will be responsible for executing routine testing for in-process, release and stability testing, environmental monitoring, utility testing, etc., as appropriate for the role. The Specialist will have similar responsibilities while also supporting general lab operations and acting as a delegate for lab management. The Senior Specialist will perform routine testing, environmental monitoring, utility testing, housekeeping, trending, projects, mentoring and training of colleagues, and may act as a team lead.

• Execute routine testing, environmental monitoring, utility testing, etc., as appropriate for the individual role.
• Perform release/stability testing for Compendia methods on intermediate or finished product.
• 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.
• Collaborate with the team lead/manager to coordinate and schedule assignments, offering valuable input to optimize the team's workflow.
• Perform data verification and review.
• Analyze laboratory data to identify and react to emerging trends, ensuring that potential issues are addressed proactively and product quality remains within established acceptance criteria.
• Record performance metrics and analyze trending data.
• May update QC documents for managerial review and approval.
• Contribute to and lead simple projects within the team; also contribute to complex projects.
• May train colleagues in the execution of tasks and testing.
• Contribute to change controls.
• Support deviation investigations and laboratory investigations through data gathering or interview process; may lead no impact deviations and lab investigations.
• Identify and escalation challenges & barriers to execution, suggest solutions, and participate in remediation.
• Identify and escalation method and/or instrument issues; also support solutions.
• Actively and positively learn and participate in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team.
• Maintain a positive, supportive, and collaborative attitude within the team.
• Complete all required tasks compliantly and safely while consistently and intentionally modelling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).
• Perform other tasks as assigned.
• Understand and follow procedures.
• Work in a fast‑paced team environment, meet deadlines, and adjust to changing priorities.
• Communicate effectively with peers and management regarding task completion, roadblocks, and needs.
• Pay attention to detail and demonstrate organizational skills.
• Manage multiple assignments while meeting timelines.
• Have knowledge of basic electronic systems (email, MS Office, etc.) and lab data systems (e.g. LIMS).
• Demonstrate experience with basic activities performed within the specific laboratory setting.
• Exhibit excellent organizational and critical‑thinking skills.

• Bachelor's degree required.
• An equivalent combination of education and experience, preferably in a regulated environment, will be considered.

• Work in teams and have continual interaction with members of the team as well as other sub-teams within QC or cross‑functionally outside of QC, to exchange information regarding testing completed, in process and planned.
• Daily contact with supervisory staff for work assignments and routine coaching and general performance management discussions.
• Occasional contact with other line management staff relating to specific project responsibilities may be expected.
• May represent QC sub‑team or functional area in cross‑functional teams or projects.
• Primarily work in a cGMP laboratory and follow techniques which require a high attention to detail, proper use of Personal Protective Equipment (PPE), and handling of hazardous materials.
• Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility.
• Flexibility to work irregular hours and short notice overtime.
• Observe work area and related tools, identify and…