Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Bristol-Myers Squibb
Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Job Description
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. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. 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 escalate 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. 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.
Key Responsibilities
- Provide routine Quality on-the-floor oversight
- Triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations
- Interpret problems and effectively prepare surrounding communication to management and the group
- Identify departures from approved procedures and respond to issues independently
- Escalate 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
- 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
Required Qualifications
- Bachelor's degree in STEM field
- High school diploma or associate's degree with equivalent combination of education and work experience
- + years of relevant cGMP experience
- + year of manufacturing site experience
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Skills Required
- Action-oriented
- Proficient in decision-making
- Building relationships
- Problem-solving
- 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 escalate
- 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.
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
75,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Action-orientedintermediate
- Proficient in decision-makingintermediate
- Building relationshipsintermediate
- Problem-solvingintermediate
- Analytical thinkingintermediate
- Ability to understand, follow, and apply internal policies, procedures, and quality principlesintermediate
- Prior experience with quality processes including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA managementintermediate
- Ability to assess an unfolding situation, diagnose the problem, and propose practical solutionsintermediate
- Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned workintermediate
- Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraintsintermediate
- Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skillsintermediate
- Active listening skills to understand diverse working perspectivesintermediate
- Contributes to a positive team environmentintermediate
- Able to independently make decisions based on data and facts, and recognizes when to escalateintermediate
- Seeks opportunities for improvement to quality and operational problemsintermediate
- Ability to work within pharmaceutical cleanroom environmentsintermediate
- Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA managementintermediate
- 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/formsintermediate
- Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.intermediate
Required Qualifications
- Bachelor's degree in STEM field (experience)
- High school diploma or associate's degree with equivalent combination of education and work experience (experience)
- + years of relevant cGMP experience (experience)
- + year of manufacturing site experience (experience)
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Responsibilities
- Provide routine Quality on-the-floor oversight
- Triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations
- Interpret problems and effectively prepare surrounding communication to management and the group
- Identify departures from approved procedures and respond to issues independently
- Escalate 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
- 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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA @ Bristol-Myers Squibb.
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Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Bristol-Myers Squibb
Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Job Description
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. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. 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 escalate 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. 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.
Key Responsibilities
- Provide routine Quality on-the-floor oversight
- Triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations
- Interpret problems and effectively prepare surrounding communication to management and the group
- Identify departures from approved procedures and respond to issues independently
- Escalate 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
- 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
Required Qualifications
- Bachelor's degree in STEM field
- High school diploma or associate's degree with equivalent combination of education and work experience
- + years of relevant cGMP experience
- + year of manufacturing site experience
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Skills Required
- Action-oriented
- Proficient in decision-making
- Building relationships
- Problem-solving
- 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 escalate
- 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.
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
75,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Action-orientedintermediate
- Proficient in decision-makingintermediate
- Building relationshipsintermediate
- Problem-solvingintermediate
- Analytical thinkingintermediate
- Ability to understand, follow, and apply internal policies, procedures, and quality principlesintermediate
- Prior experience with quality processes including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA managementintermediate
- Ability to assess an unfolding situation, diagnose the problem, and propose practical solutionsintermediate
- Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned workintermediate
- Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraintsintermediate
- Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skillsintermediate
- Active listening skills to understand diverse working perspectivesintermediate
- Contributes to a positive team environmentintermediate
- Able to independently make decisions based on data and facts, and recognizes when to escalateintermediate
- Seeks opportunities for improvement to quality and operational problemsintermediate
- Ability to work within pharmaceutical cleanroom environmentsintermediate
- Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA managementintermediate
- 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/formsintermediate
- Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.intermediate
Required Qualifications
- Bachelor's degree in STEM field (experience)
- High school diploma or associate's degree with equivalent combination of education and work experience (experience)
- + years of relevant cGMP experience (experience)
- + year of manufacturing site experience (experience)
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Responsibilities
- Provide routine Quality on-the-floor oversight
- Triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations
- Interpret problems and effectively prepare surrounding communication to management and the group
- Identify departures from approved procedures and respond to issues independently
- Escalate 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
- 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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs