Specialist, Shop Floor Quality Assurance, Night Shift - Bristol Myers Squibb
Devens, MA
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
This role works on a rotating night shift schedule from 6pm-6am.
Position Summary:
The Specialist, Shop Floor Quality Assurance is responsible for supporting shop-floor activities in manufacturing operations at Devens in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). Functional responsibilities include triaging and supporting the resolution of unexpected events in conjunction with area owners; proactively monitoring process performance and identifying departures from accepted standards; conduct routine reviews and approvals of GxP documents including, but not limited to electronic batch record review, and logbooks; executing operational tasks in the electronic batch records such as, but not limited, to disposition of incoming apheresis patient material.
The Shop Floor Quality Assurance Manufacturing team is primarily responsible for oversight of production and adjacent activities which support the creation of autologous Cell Therapy drug products. Individuals of this team are expected to have a presence on-the-floor during which they apply knowledge of cGMP, BMS policies, and regulatory requirements to ensure patient safety. Team members are expected to partner routinely with counterparts in manufacturing to assess and continuously improve the general state of the facility and operations. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed as we are often the first members of the Quality Unit to be contacted for routine and non-routine activities supporting operations.
Key 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 & 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
Education & Experience:
+ 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.
+ Must be action-oriented and proficient with 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 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.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586026
Updated: 2024-10-08 02:16:50.162 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
This role works on a rotating night shift schedule from 6pm-6am.
Position Summary:
The Specialist, Shop Floor Quality Assurance is responsible for supporting shop-floor activities in manufacturing operations at Devens in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). Functional responsibilities include triaging and supporting the resolution of unexpected events in conjunction with area owners; proactively monitoring process performance and identifying departures from accepted standards; conduct routine reviews and approvals of GxP documents including, but not limited to electronic batch record review, and logbooks; executing operational tasks in the electronic batch records such as, but not limited, to disposition of incoming apheresis patient material.
The Shop Floor Quality Assurance Manufacturing team is primarily responsible for oversight of production and adjacent activities which support the creation of autologous Cell Therapy drug products. Individuals of this team are expected to have a presence on-the-floor during which they apply knowledge of cGMP, BMS policies, and regulatory requirements to ensure patient safety. Team members are expected to partner routinely with counterparts in manufacturing to assess and continuously improve the general state of the facility and operations. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed as we are often the first members of the Quality Unit to be contacted for routine and non-routine activities supporting operations.
Key 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 & 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
Education & Experience:
+ 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.
+ Must be action-oriented and proficient with 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 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.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586026
Updated: 2024-10-08 02:16:50.162 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb