NIGHT SHIFT: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Bristol-Myers Squibb
NIGHT SHIFT: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Job Description
They own; review or quality approve GxP records including but not limited to procedures, batch records, or deviations. Additionally, the incumbent shall support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed. Provide Quality oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management. May perform and document operational verification per approved procedures. Develops, reviews and/ or approves temporary and non routine procedure for event response. Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques. Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans. Own actions for departmental programs and propose improvements to programs. Communicate and resolve discrepancies independently and escalate as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel. May own training curriculum and content. Independently assess discrepancies for entry into quality system and approve records as applicable. Lead meetings and represent function at cross functional meetings. Share data/knowledge within and across team. Build & maintain strong relationships with partner functions. May prioritize and assign tasks for the team. Observe operations occurring on the floor and proactively identify risks and drive improvements. Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals. Able to influence others based on time and task commitments, organize/run meetings. Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.). Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting. 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. Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelines. Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications. Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions. Excellent written and verbal skills and ability to present technical data effectively based on target audience. Ability to work in a fast-paced team environment and lead peers through changing priorities. Detail oriented and task focused with ability to meet deadlines and support work prioritization. Ability to negotiate and influence to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Demonstrated experience with quality management systems Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
About the Role/Company
- The company values effective communication, critical thinking, and continuous learning within the Shop Floor Quality Assurance team
Key Responsibilities
- Own, review, or quality approve GxP records including procedures, batch records, or deviations
- Support deviation approval, alarm approval, and other Quality System Records as requested by management
- Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations
- Identify departures from approved procedures and respond to complex issues independently
- Escalate critical issues to management
- Perform and document operational verification per approved procedures
- Develop, review, and/or approve temporary and non-routine procedures for event response
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Coordinate and lead area walkthroughs to identify quality issues
- Negotiate remediations and drive alignment of implementation plans
- Own actions for departmental programs and propose improvements to programs
- Communicate and resolve discrepancies independently and escalate as required
- Author, review, and approve procedural documents
- Maintain compliance with assigned learning plan
- Provide guidance and training for QA personnel
- Own training curriculum and content
- Independently assess discrepancies for entry into quality system and approve records as applicable
- Lead meetings and represent function at cross-functional meetings
- Share data/knowledge within and across team
- Build and maintain strong relationships with partner functions
- Prioritize and assign tasks for the team
- Observe operations occurring on the floor and proactively identify risks and drive improvements
- Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals
- Influence others based on time and task commitments, organize/run meetings
- Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.)
Required Qualifications
- Bachelor's degree in STEM field preferred
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered
- + years of relevant cGMP experience
- Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management
- Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms
Preferred Qualifications
- + year of manufacturing site experience
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Skills Required
- Effective communication
- Critical thinking
- Thirst for knowledge
- Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelines
- Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications
- Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions
- Excellent written and verbal skills and ability to present technical data effectively based on target audience
- Ability to work in a fast-paced team environment and lead peers through changing priorities
- Detail oriented and task focused with ability to meet deadlines and support work prioritization
- Ability to negotiate and influence to craft mutually beneficial solutions
- Ability to motivate and foster a positive team environment
- Exhibit strong decision-making ability and think creatively while maintaining compliance and quality
- Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
- Familiarity with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting
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
Additional Requirements
- Night shift work schedule
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
100,000 - 140,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Effective communicationintermediate
- Critical thinkingintermediate
- Thirst for knowledgeintermediate
- Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelinesintermediate
- Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applicationsintermediate
- Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutionsintermediate
- Excellent written and verbal skills and ability to present technical data effectively based on target audienceintermediate
- Ability to work in a fast-paced team environment and lead peers through changing prioritiesintermediate
- Detail oriented and task focused with ability to meet deadlines and support work prioritizationintermediate
- Ability to negotiate and influence to craft mutually beneficial solutionsintermediate
- Ability to motivate and foster a positive team environmentintermediate
- Exhibit strong decision-making ability and think creatively while maintaining compliance and qualityintermediate
- Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.intermediate
- Familiarity with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reportingintermediate
Required Qualifications
- Bachelor's degree in STEM field preferred (experience)
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered (experience)
- + years of relevant cGMP experience (experience)
- Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management (experience)
- Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms (experience)
Preferred Qualifications
- + year of manufacturing site experience (experience)
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Responsibilities
- Own, review, or quality approve GxP records including procedures, batch records, or deviations
- Support deviation approval, alarm approval, and other Quality System Records as requested by management
- Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations
- Identify departures from approved procedures and respond to complex issues independently
- Escalate critical issues to management
- Perform and document operational verification per approved procedures
- Develop, review, and/or approve temporary and non-routine procedures for event response
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Coordinate and lead area walkthroughs to identify quality issues
- Negotiate remediations and drive alignment of implementation plans
- Own actions for departmental programs and propose improvements to programs
- Communicate and resolve discrepancies independently and escalate as required
- Author, review, and approve procedural documents
- Maintain compliance with assigned learning plan
- Provide guidance and training for QA personnel
- Own training curriculum and content
- Independently assess discrepancies for entry into quality system and approve records as applicable
- Lead meetings and represent function at cross-functional meetings
- Share data/knowledge within and across team
- Build and maintain strong relationships with partner functions
- Prioritize and assign tasks for the team
- Observe operations occurring on the floor and proactively identify risks and drive improvements
- Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals
- Influence others based on time and task commitments, organize/run meetings
- Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.)
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
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NIGHT SHIFT: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Bristol-Myers Squibb
NIGHT SHIFT: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Job Description
They own; review or quality approve GxP records including but not limited to procedures, batch records, or deviations. Additionally, the incumbent shall support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed. Provide Quality oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management. May perform and document operational verification per approved procedures. Develops, reviews and/ or approves temporary and non routine procedure for event response. Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques. Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans. Own actions for departmental programs and propose improvements to programs. Communicate and resolve discrepancies independently and escalate as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel. May own training curriculum and content. Independently assess discrepancies for entry into quality system and approve records as applicable. Lead meetings and represent function at cross functional meetings. Share data/knowledge within and across team. Build & maintain strong relationships with partner functions. May prioritize and assign tasks for the team. Observe operations occurring on the floor and proactively identify risks and drive improvements. Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals. Able to influence others based on time and task commitments, organize/run meetings. Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.). Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting. 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. Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelines. Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications. Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions. Excellent written and verbal skills and ability to present technical data effectively based on target audience. Ability to work in a fast-paced team environment and lead peers through changing priorities. Detail oriented and task focused with ability to meet deadlines and support work prioritization. Ability to negotiate and influence to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Demonstrated experience with quality management systems Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
About the Role/Company
- The company values effective communication, critical thinking, and continuous learning within the Shop Floor Quality Assurance team
Key Responsibilities
- Own, review, or quality approve GxP records including procedures, batch records, or deviations
- Support deviation approval, alarm approval, and other Quality System Records as requested by management
- Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations
- Identify departures from approved procedures and respond to complex issues independently
- Escalate critical issues to management
- Perform and document operational verification per approved procedures
- Develop, review, and/or approve temporary and non-routine procedures for event response
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Coordinate and lead area walkthroughs to identify quality issues
- Negotiate remediations and drive alignment of implementation plans
- Own actions for departmental programs and propose improvements to programs
- Communicate and resolve discrepancies independently and escalate as required
- Author, review, and approve procedural documents
- Maintain compliance with assigned learning plan
- Provide guidance and training for QA personnel
- Own training curriculum and content
- Independently assess discrepancies for entry into quality system and approve records as applicable
- Lead meetings and represent function at cross-functional meetings
- Share data/knowledge within and across team
- Build and maintain strong relationships with partner functions
- Prioritize and assign tasks for the team
- Observe operations occurring on the floor and proactively identify risks and drive improvements
- Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals
- Influence others based on time and task commitments, organize/run meetings
- Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.)
Required Qualifications
- Bachelor's degree in STEM field preferred
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered
- + years of relevant cGMP experience
- Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management
- Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms
Preferred Qualifications
- + year of manufacturing site experience
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Skills Required
- Effective communication
- Critical thinking
- Thirst for knowledge
- Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelines
- Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications
- Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions
- Excellent written and verbal skills and ability to present technical data effectively based on target audience
- Ability to work in a fast-paced team environment and lead peers through changing priorities
- Detail oriented and task focused with ability to meet deadlines and support work prioritization
- Ability to negotiate and influence to craft mutually beneficial solutions
- Ability to motivate and foster a positive team environment
- Exhibit strong decision-making ability and think creatively while maintaining compliance and quality
- Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
- Familiarity with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting
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
Additional Requirements
- Night shift work schedule
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
100,000 - 140,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Effective communicationintermediate
- Critical thinkingintermediate
- Thirst for knowledgeintermediate
- Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelinesintermediate
- Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applicationsintermediate
- Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutionsintermediate
- Excellent written and verbal skills and ability to present technical data effectively based on target audienceintermediate
- Ability to work in a fast-paced team environment and lead peers through changing prioritiesintermediate
- Detail oriented and task focused with ability to meet deadlines and support work prioritizationintermediate
- Ability to negotiate and influence to craft mutually beneficial solutionsintermediate
- Ability to motivate and foster a positive team environmentintermediate
- Exhibit strong decision-making ability and think creatively while maintaining compliance and qualityintermediate
- Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.intermediate
- Familiarity with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reportingintermediate
Required Qualifications
- Bachelor's degree in STEM field preferred (experience)
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered (experience)
- + years of relevant cGMP experience (experience)
- Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management (experience)
- Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms (experience)
Preferred Qualifications
- + year of manufacturing site experience (experience)
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Responsibilities
- Own, review, or quality approve GxP records including procedures, batch records, or deviations
- Support deviation approval, alarm approval, and other Quality System Records as requested by management
- Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations
- Identify departures from approved procedures and respond to complex issues independently
- Escalate critical issues to management
- Perform and document operational verification per approved procedures
- Develop, review, and/or approve temporary and non-routine procedures for event response
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Coordinate and lead area walkthroughs to identify quality issues
- Negotiate remediations and drive alignment of implementation plans
- Own actions for departmental programs and propose improvements to programs
- Communicate and resolve discrepancies independently and escalate as required
- Author, review, and approve procedural documents
- Maintain compliance with assigned learning plan
- Provide guidance and training for QA personnel
- Own training curriculum and content
- Independently assess discrepancies for entry into quality system and approve records as applicable
- Lead meetings and represent function at cross-functional meetings
- Share data/knowledge within and across team
- Build and maintain strong relationships with partner functions
- Prioritize and assign tasks for the team
- Observe operations occurring on the floor and proactively identify risks and drive improvements
- Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals
- Influence others based on time and task commitments, organize/run meetings
- Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.)
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 NIGHT SHIFT: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs