Sr Specialist, QA Shop Floor - Bristol Myers Squibb
Summit, NJ
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 .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Sr. Specialist role is a combined role working 50% Technical Writer role and 50% Specialist role within the QA Shop floor Department that provides quality oversight in the manufacturing areas of S12. Tech Writer role works independently and is responsible for authoring high-quality documentation in support of GMP manufacturing. This includes but is not limited to deviation investigations, CAPA's, SOP's and Work Practices (Equipment, personnel, manufacturing, and batch records). Specialist role is responsible for quality activities for the QA shop floor program in accordance with BMS 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.
Shift Available:
+ Wednesday - Saturday (Every other Wednesday off), Onsite overnight shift, 5 p.m. - 5:30 a.m.
Responsibilities:
Tech Writer:
+ Author and revise GMP documents as needed.
+ Assist in executing change controls where needed.
+ Create tutorials to help end-users train on a variety of activities.
+ Create and maintain documentation projects and timelines.
Specialist:
+ Perform Quality Assurance oversight of manufacturing and site activities.
+ Ensure manufacturing compliance with cGMPs, applicable procedures, and batch records.
+ Perform real time review of manufacturing batch records, logbooks, and ancillary documents.
+ Perform product label reconciliation for Manufacturing Operations.
+ Perform GMP Walk-throughs of manufacturing and site areas.
+ Write and approve deviations.
+ Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Knowledge & Skills:
Technical Writing
+ Proven working experience in writing GMP documents.
+ Ability to deliver high-quality documentation under accelerated timelines.
+ Ability to quickly grasp complex technical concepts and make them easily understandable in text.
+ Advanced ability to work in a collaborative team environment and train others.
+ Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.
+ Good organizational skills and critical thinking skills.
+ Excellent written skills in English.
+ Strong working knowledge of Microsoft Office.
Specialist:
+ Must have advanced knowledge and experience with cGMP, Quality Assurance, and compliance.
+ Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
+ Confident in making decisions for routine/recurring issues.
+ Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues.
+ Understands continuous improvement and improves efficiency and productivity within the group or project.
+ Able to recognize conflict and notify management with proposed recommendations for resolution.
+ Able to effectively communicate and collaborate with other departments when addressing Quality issues.
+ Able to effectively multi-task.
+ Excellent verbal and written communication skills.
+ Able to critically review investigations, interpret results, generate technical conclusions, and make recommendations consistent with Quality Risk Management principles.
Basic Requirements:
+ Bachelor's Degree preferred. An equivalent combination of education and experience will be considered.
+ Minimum of 3 years in Quality Assurance within a manufacturing GMP facility.
+ 1 year of direct experience with writing deviations and reviewing investigations.
Working Conditions:
+ The incumbent will work 40 hours per week, including some weekends and holidays if needed.
+ The incumbent may be sitting at a desk and using a computer for prolonged periods of time, up to 8 hours per day.
+ The incumbent may be entering and/or working in a GMP controlled environment.
+ The incumbent may be in the vicinity of biohazardous materials when entering the controlled environments.
BMSCART, #LI-Onsite
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: R1585039
Updated: 2024-09-20 04:55:51.385 UTC
Location: Summit West-NJ
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 .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Sr. Specialist role is a combined role working 50% Technical Writer role and 50% Specialist role within the QA Shop floor Department that provides quality oversight in the manufacturing areas of S12. Tech Writer role works independently and is responsible for authoring high-quality documentation in support of GMP manufacturing. This includes but is not limited to deviation investigations, CAPA's, SOP's and Work Practices (Equipment, personnel, manufacturing, and batch records). Specialist role is responsible for quality activities for the QA shop floor program in accordance with BMS 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.
Shift Available:
+ Wednesday - Saturday (Every other Wednesday off), Onsite overnight shift, 5 p.m. - 5:30 a.m.
Responsibilities:
Tech Writer:
+ Author and revise GMP documents as needed.
+ Assist in executing change controls where needed.
+ Create tutorials to help end-users train on a variety of activities.
+ Create and maintain documentation projects and timelines.
Specialist:
+ Perform Quality Assurance oversight of manufacturing and site activities.
+ Ensure manufacturing compliance with cGMPs, applicable procedures, and batch records.
+ Perform real time review of manufacturing batch records, logbooks, and ancillary documents.
+ Perform product label reconciliation for Manufacturing Operations.
+ Perform GMP Walk-throughs of manufacturing and site areas.
+ Write and approve deviations.
+ Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Knowledge & Skills:
Technical Writing
+ Proven working experience in writing GMP documents.
+ Ability to deliver high-quality documentation under accelerated timelines.
+ Ability to quickly grasp complex technical concepts and make them easily understandable in text.
+ Advanced ability to work in a collaborative team environment and train others.
+ Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.
+ Good organizational skills and critical thinking skills.
+ Excellent written skills in English.
+ Strong working knowledge of Microsoft Office.
Specialist:
+ Must have advanced knowledge and experience with cGMP, Quality Assurance, and compliance.
+ Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
+ Confident in making decisions for routine/recurring issues.
+ Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues.
+ Understands continuous improvement and improves efficiency and productivity within the group or project.
+ Able to recognize conflict and notify management with proposed recommendations for resolution.
+ Able to effectively communicate and collaborate with other departments when addressing Quality issues.
+ Able to effectively multi-task.
+ Excellent verbal and written communication skills.
+ Able to critically review investigations, interpret results, generate technical conclusions, and make recommendations consistent with Quality Risk Management principles.
Basic Requirements:
+ Bachelor's Degree preferred. An equivalent combination of education and experience will be considered.
+ Minimum of 3 years in Quality Assurance within a manufacturing GMP facility.
+ 1 year of direct experience with writing deviations and reviewing investigations.
Working Conditions:
+ The incumbent will work 40 hours per week, including some weekends and holidays if needed.
+ The incumbent may be sitting at a desk and using a computer for prolonged periods of time, up to 8 hours per day.
+ The incumbent may be entering and/or working in a GMP controlled environment.
+ The incumbent may be in the vicinity of biohazardous materials when entering the controlled environments.
BMSCART, #LI-Onsite
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: R1585039
Updated: 2024-09-20 04:55:51.385 UTC
Location: Summit West-NJ
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
