Manager, QA Shopfloor - 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 .
PURPOSE AND SCOPE OF POSITION:
The Manager, Field Quality Assurance, Cell Therapy is responsible for quality activities for the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Field QA Manager role is stationed in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF.
This position works on a rotating night shift from 6pm - 6am
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
+ Previous Supervisory/Managerial Experience 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 FDA 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 little direction to complete more complex tasks; completes routine tasks with little or no supervision.
+ Able to provide directions to others within the team.
+ 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 US and global cGMP requirements.
DUTIES AND RESPONSIBILITIES
+ Oversee performance of QA shop floor activities.
+ Supervise Field Quality Assurance employees.
+ Ensure manufacturing compliance with applicable procedures and batch records.
+ Perform real time review of manufacturing batch records.
+ Review manufacturing shop floor 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 CAPA management.
EDUCATION AND EXPERIENCE
+ Supervisory experience highly preferred.
+ High School Degree required.
+ Relevant college or university degree preferred.
+ Minimum 6+ years relevant work experience, with at least 3 years in a Quality Assurance role.
+ Equivalent combination of education and experience acceptable.
WORKING CONDITIONS: PHYSICAL /MENTAL DEMANDS:
+ Able to lift up-to 25 pounds several times a day.
+ Able to stand and walk for several hours at a time in a 12-hour shift.
+ Able to move between rooms in a timely manner.
+ Able to work near strong magnetic fields.
+ Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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: R1584730
Updated: 2024-09-20 04:55:51.220 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 .
PURPOSE AND SCOPE OF POSITION:
The Manager, Field Quality Assurance, Cell Therapy is responsible for quality activities for the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Field QA Manager role is stationed in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF.
This position works on a rotating night shift from 6pm - 6am
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
+ Previous Supervisory/Managerial Experience 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 FDA 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 little direction to complete more complex tasks; completes routine tasks with little or no supervision.
+ Able to provide directions to others within the team.
+ 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 US and global cGMP requirements.
DUTIES AND RESPONSIBILITIES
+ Oversee performance of QA shop floor activities.
+ Supervise Field Quality Assurance employees.
+ Ensure manufacturing compliance with applicable procedures and batch records.
+ Perform real time review of manufacturing batch records.
+ Review manufacturing shop floor 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 CAPA management.
EDUCATION AND EXPERIENCE
+ Supervisory experience highly preferred.
+ High School Degree required.
+ Relevant college or university degree preferred.
+ Minimum 6+ years relevant work experience, with at least 3 years in a Quality Assurance role.
+ Equivalent combination of education and experience acceptable.
WORKING CONDITIONS: PHYSICAL /MENTAL DEMANDS:
+ Able to lift up-to 25 pounds several times a day.
+ Able to stand and walk for several hours at a time in a 12-hour shift.
+ Able to move between rooms in a timely manner.
+ Able to work near strong magnetic fields.
+ Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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: R1584730
Updated: 2024-09-20 04:55:51.220 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
