QC Associate

The Associate role will be responsible for executing routine testing for in-process, release and stability, environmental monitoring, utility testing etc as appropriate for the individual role. They will also support general lab operations and maintenance activities, as required. The Specialist in this role will be responsible for executing routine testing, environmental monitoring, utility testing etc. as appropriate for the individual role.

They will also support lab operations activities such as housekeeping, and act as delegate for lab management as required. The Senior Specialist role will be responsible for executing routine testing, environmental monitoring, utility testing, etc., as appropriate for the individual role/team. They will also support lab operations activities, such as housekeeping, trending, projects etc. as required. They will help mentor and train colleagues, input into scheduling and planning, and act as delegate for lab management as required.

The Specialist and Senior Specialists may be considered team leads for their respective teams.

• Executes 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.
• Collaborates 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.
• Records performance metrics and analyzes trending data
• May update QC documents for managerial review and approval.
• Contributes to and leads simple projects within the team. Also contributes to complex projects.
• May train colleagues in the execution of tasks and testing.
• Contributes to change controls.
• 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.
• Identifies and escalates method and/or instrument issues. Also supports solutions.
• 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.
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).
• Perform other tasks as assigned
• Ability to understand and follow procedures.
• Ability to work in a fast-paced team environment, meet deadlines, and adjust to changing priorities.
• Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
• Attention to detail and demonstrate organizational skills.
• Ability to manage multiple assignments while meeting timelines
• Knowledge of basic electronic systems (email, MS Office, etc.) and lab data systems (e.g. LIMS) required
• Demonstrated experience with basic activities performed within the specific laboratory setting.
• 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.

• Will work in teams and have continual interaction with members of their team as well as other sub-teams within QC, or cross-functionally outside of QC, in order to exchange information regarding testing completed, in process and planned.
• Daily contact with their supervisory staff for work assignments. Routine contact with supervisor for 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 one to be alert, giving a high attention to detail, to properly use Personal Protective…