Senior Specialist, QA Operations Shopfloor
Bristol-Myers Squibb
Senior Specialist, QA Operations Shopfloor
Job Description
Perform QA shopfloor activities. Ensure manufacturing compliance with applicable procedures and batch records. Perform real time review of manufacturing batch records. Review manufacturing shopfloor documentation. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. Must be skilled in planning and organizing, decision-making, and building relationships. Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) management. Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) is preferred. High school diploma/ Associate's degree with equivalent combination of education and work experience is acceptable. 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 Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Understands continuous improvement and improves efficiency and productivity within the group or project. Builds relationships internally within and with cross functional teams. Must have sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes. Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies. Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Able to recognize conflict and notify management with proposed recommendations for resolution. Must possess an independent mindset. Work is self-directed. Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Confident in making decisions for non-routine issues. Develops and revises procedures. Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Able to prepare written communications and communicate problems to management with clarity and accuracy. Able to effectively multi-task. Knowledge of global cGMP requirement
Key Responsibilities
- Perform QA shopfloor activities
- Ensure manufacturing compliance with applicable procedures and batch records
- Perform real time review of manufacturing batch records
- Review manufacturing shopfloor documentation
- Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
- Routinely recognize and resolve Quality issues; inform management of proposed solutions
- Seek management guidance on complex issues
- Recognize conflict and notify management with proposed recommendations for resolution
- Develop and revise procedures
- Prepare written communications and communicate problems to management with clarity and accuracy
Required Qualifications
- Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) or High school diploma/Associate's degree with equivalent combination of education and work experience
- + years of relevant cGMP experience
Preferred Qualifications
- + year of manufacturing site experience
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
- Knowledge of GMP Manufacturing operations and processes
Skills Required
- Strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
- Skilled in planning and organizing, decision-making, and building relationships
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) management
- Action-oriented
- Skilled in problem solving, conflict management, resource allocation, coaching others, and analytical thinking
- Understands continuous improvement and improves efficiency and productivity within the group or project
- Sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
- Able to effectively multi-task
- Knowledge of global cGMP requirements
- Confident in making decisions for non-routine issues
- Possess an independent mindset
- Work is self-directed
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
Locations
- Leiden – NL, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
90,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principlesintermediate
- Skilled in planning and organizing, decision-making, and building relationshipsintermediate
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) managementintermediate
- Action-orientedintermediate
- Skilled in problem solving, conflict management, resource allocation, coaching others, and analytical thinkingintermediate
- Understands continuous improvement and improves efficiency and productivity within the group or projectintermediate
- Sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environmentsintermediate
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolutionintermediate
- Able to effectively multi-taskintermediate
- Knowledge of global cGMP requirementsintermediate
- Confident in making decisions for non-routine issuesintermediate
- Possess an independent mindsetintermediate
- Work is self-directedintermediate
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervisionintermediate
Required Qualifications
- Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) or High school diploma/Associate's degree with equivalent combination of education and work experience (experience)
- + years of relevant cGMP experience (experience)
Preferred Qualifications
- + year of manufacturing site experience (experience)
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
- Knowledge of GMP Manufacturing operations and processes (experience)
Responsibilities
- Perform QA shopfloor activities
- Ensure manufacturing compliance with applicable procedures and batch records
- Perform real time review of manufacturing batch records
- Review manufacturing shopfloor documentation
- Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
- Routinely recognize and resolve Quality issues; inform management of proposed solutions
- Seek management guidance on complex issues
- Recognize conflict and notify management with proposed recommendations for resolution
- Develop and revise procedures
- Prepare written communications and communicate problems to management with clarity and accuracy
Tags & Categories
Senior Specialist, QA Operations Shopfloor
Bristol-Myers Squibb
Senior Specialist, QA Operations Shopfloor
Job Description
Perform QA shopfloor activities. Ensure manufacturing compliance with applicable procedures and batch records. Perform real time review of manufacturing batch records. Review manufacturing shopfloor documentation. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. Must be skilled in planning and organizing, decision-making, and building relationships. Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) management. Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) is preferred. High school diploma/ Associate's degree with equivalent combination of education and work experience is acceptable. 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 Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Understands continuous improvement and improves efficiency and productivity within the group or project. Builds relationships internally within and with cross functional teams. Must have sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes. Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies. Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Able to recognize conflict and notify management with proposed recommendations for resolution. Must possess an independent mindset. Work is self-directed. Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Confident in making decisions for non-routine issues. Develops and revises procedures. Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Able to prepare written communications and communicate problems to management with clarity and accuracy. Able to effectively multi-task. Knowledge of global cGMP requirement
Key Responsibilities
- Perform QA shopfloor activities
- Ensure manufacturing compliance with applicable procedures and batch records
- Perform real time review of manufacturing batch records
- Review manufacturing shopfloor documentation
- Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
- Routinely recognize and resolve Quality issues; inform management of proposed solutions
- Seek management guidance on complex issues
- Recognize conflict and notify management with proposed recommendations for resolution
- Develop and revise procedures
- Prepare written communications and communicate problems to management with clarity and accuracy
Required Qualifications
- Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) or High school diploma/Associate's degree with equivalent combination of education and work experience
- + years of relevant cGMP experience
Preferred Qualifications
- + year of manufacturing site experience
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
- Knowledge of GMP Manufacturing operations and processes
Skills Required
- Strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
- Skilled in planning and organizing, decision-making, and building relationships
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) management
- Action-oriented
- Skilled in problem solving, conflict management, resource allocation, coaching others, and analytical thinking
- Understands continuous improvement and improves efficiency and productivity within the group or project
- Sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
- Able to effectively multi-task
- Knowledge of global cGMP requirements
- Confident in making decisions for non-routine issues
- Possess an independent mindset
- Work is self-directed
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
Locations
- Leiden – NL, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
90,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principlesintermediate
- Skilled in planning and organizing, decision-making, and building relationshipsintermediate
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) managementintermediate
- Action-orientedintermediate
- Skilled in problem solving, conflict management, resource allocation, coaching others, and analytical thinkingintermediate
- Understands continuous improvement and improves efficiency and productivity within the group or projectintermediate
- Sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environmentsintermediate
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolutionintermediate
- Able to effectively multi-taskintermediate
- Knowledge of global cGMP requirementsintermediate
- Confident in making decisions for non-routine issuesintermediate
- Possess an independent mindsetintermediate
- Work is self-directedintermediate
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervisionintermediate
Required Qualifications
- Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) or High school diploma/Associate's degree with equivalent combination of education and work experience (experience)
- + years of relevant cGMP experience (experience)
Preferred Qualifications
- + year of manufacturing site experience (experience)
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
- Knowledge of GMP Manufacturing operations and processes (experience)
Responsibilities
- Perform QA shopfloor activities
- Ensure manufacturing compliance with applicable procedures and batch records
- Perform real time review of manufacturing batch records
- Review manufacturing shopfloor documentation
- Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
- Routinely recognize and resolve Quality issues; inform management of proposed solutions
- Seek management guidance on complex issues
- Recognize conflict and notify management with proposed recommendations for resolution
- Develop and revise procedures
- Prepare written communications and communicate problems to management with clarity and accuracy
Tags & Categories