Bristol Myers Squibb
Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Specialist, Quality Assurance Shop Floor, Cell Therapy – Devens, MA
Specialist, Quality Assurance Shop Floor, Cell Therapy – Devens, MA – Bristol Myers Squibb – Devens, MA – Full‑time – Associate – Quality Assurance – Pharmaceutical Manufacturing.
Shifts Available 6am – 6pm, rotating scheduling including holidays and weekends, onsite.
Responsibilities
Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
Provide quality oversight for pre-planned return to service plans.
Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
Identify and propose improvements to programs, procedures, and practices.
Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
Review and provide feedback on documents such as forms, logbooks, and procedures.
Maintain compliance with assigned learning plan. Provide integration support of newer team members.
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
Participate in quality and shift meetings.
Build and maintain relationships with core partner functions and seek collaborative solutions.
Share data/knowledge within team by acting as a champion for quality-culture.
Knowledge and Skills
Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.
Ability to understand, follow, and apply internal policies, procedures, and quality principles.
Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions.
Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.
Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
Active listening skills to understand diverse working perspectives.
Contributes to a positive team environment.
Able to independently make decisions based on data and facts, and recognizes when to elevate.
Seeks opportunities for improvement to quality and operational problems.
Ability to work within pharmaceutical cleanroom environments.
Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
Basic Requirements
Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered.
2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
Compensation Overview Devens, MA – US: $83,540 – $101,228.
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Benefit Offerings Subject To The Terms And Conditions Of The Applicable Plans In Effect At The Time And May Require Enrollment. Our Benefits Include:
Health Coverage: Medical, pharmacy, dental and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.
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Shifts Available 6am – 6pm, rotating scheduling including holidays and weekends, onsite.
Responsibilities
Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
Provide quality oversight for pre-planned return to service plans.
Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
Identify and propose improvements to programs, procedures, and practices.
Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
Review and provide feedback on documents such as forms, logbooks, and procedures.
Maintain compliance with assigned learning plan. Provide integration support of newer team members.
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
Participate in quality and shift meetings.
Build and maintain relationships with core partner functions and seek collaborative solutions.
Share data/knowledge within team by acting as a champion for quality-culture.
Knowledge and Skills
Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.
Ability to understand, follow, and apply internal policies, procedures, and quality principles.
Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions.
Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.
Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
Active listening skills to understand diverse working perspectives.
Contributes to a positive team environment.
Able to independently make decisions based on data and facts, and recognizes when to elevate.
Seeks opportunities for improvement to quality and operational problems.
Ability to work within pharmaceutical cleanroom environments.
Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
Basic Requirements
Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered.
2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
Compensation Overview Devens, MA – US: $83,540 – $101,228.
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Benefit Offerings Subject To The Terms And Conditions Of The Applicable Plans In Effect At The Time And May Require Enrollment. Our Benefits Include:
Health Coverage: Medical, pharmacy, dental and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.
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