Senior Specialist, Quality Assurance Label Control - 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 Quality Assurance Label Control Senior Specialist at the S-12 Cell Therapy m anufacturing facility is responsible for supporting site Label Control activities at S-12 in accordance with BMS policies, standards, procedures and Global cGMPs. Functional responsibilities include performing in-process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).
Shift Available:
+ Wednesday-Saturday, Onsite, 4 p.m. - 2:00 a.m.
Responsibilities:
+ Supports all activities for the Quality Assurance Label Control group.
+ Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
+ Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
+ Coordinates with production teams to ensure timely issuance of labels.
+ Performs training of label control and issuance requirements for internal personnel as needed.
+ Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
+ Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
+ Provides support during internal and health authority inspections and audits of facility.
+ Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
+ Performs supplemental investigations/projects as required by Management.
+ Maintains knowledge of current GMPs and regulatory guidelines.
Knowledge & Skills:
+ Must have advanced knowledge and experience with GMP, Quality, and compliance.
+ Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.
+ Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.
+ Must be time organized and possess an independent mindset.
+ Good understanding of electronic document management and manufacturing execution systems.
+ Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
+ Confident in making decisions for non-routine issues.
+ Is recognized Subject Matter Expert within the group.
+ Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.
+ Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
+ Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
+ Contributes to goals within the work group.
+ Able to recognize conflict and notify management with proposed recommendations for resolution.
+ Able to prepare written communications and communicate problems to management with clarity and accuracy.
+ Able to produce data reports with precision.
+ Able to muti-task.
+ Able to support internal and health authority inspections of facility.
Basic Requirements:
+ Bachelor Degree required. An equivalent combination of higher education and experience will be considered.
+ A minimum 5 years of experience in a Quality Assurance role within a manufacturing GMP facility.
+ A minimum of 3 years of experience with labels.
+ MES systems experience highly desired.
+ Oracle experience preferred.
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: R1585321
Updated: 2024-09-27 01:55:13.524 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 Quality Assurance Label Control Senior Specialist at the S-12 Cell Therapy m anufacturing facility is responsible for supporting site Label Control activities at S-12 in accordance with BMS policies, standards, procedures and Global cGMPs. Functional responsibilities include performing in-process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).
Shift Available:
+ Wednesday-Saturday, Onsite, 4 p.m. - 2:00 a.m.
Responsibilities:
+ Supports all activities for the Quality Assurance Label Control group.
+ Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
+ Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
+ Coordinates with production teams to ensure timely issuance of labels.
+ Performs training of label control and issuance requirements for internal personnel as needed.
+ Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
+ Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
+ Provides support during internal and health authority inspections and audits of facility.
+ Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
+ Performs supplemental investigations/projects as required by Management.
+ Maintains knowledge of current GMPs and regulatory guidelines.
Knowledge & Skills:
+ Must have advanced knowledge and experience with GMP, Quality, and compliance.
+ Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.
+ Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.
+ Must be time organized and possess an independent mindset.
+ Good understanding of electronic document management and manufacturing execution systems.
+ Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
+ Confident in making decisions for non-routine issues.
+ Is recognized Subject Matter Expert within the group.
+ Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.
+ Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
+ Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
+ Contributes to goals within the work group.
+ Able to recognize conflict and notify management with proposed recommendations for resolution.
+ Able to prepare written communications and communicate problems to management with clarity and accuracy.
+ Able to produce data reports with precision.
+ Able to muti-task.
+ Able to support internal and health authority inspections of facility.
Basic Requirements:
+ Bachelor Degree required. An equivalent combination of higher education and experience will be considered.
+ A minimum 5 years of experience in a Quality Assurance role within a manufacturing GMP facility.
+ A minimum of 3 years of experience with labels.
+ MES systems experience highly desired.
+ Oracle experience preferred.
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: R1585321
Updated: 2024-09-27 01:55:13.524 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