Senior Specialist, QA Deviation Reviewer and Approver - 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 Specialist, QA Operations Deviation role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.
Shift Available:
+ Wednesday - Saturday, Onsite Day Shift, 8AM - 6PM
Responsibilities:
+ Supports all activities for the Quality Operations Investigations group.
+ Review and approve Site operational investigation.
+ Review and approve Supplemental actions.
+ Review and approve Impact assessments or Product Quality Evaluation Approval.
+ Review and Approve Corrective and Preventive Actions (CAPA Plan, Action approval, Effectiveness Check (EC) Plan, EC execution Approval).
+ Participate in Audit and inspection including inspection readiness activities.
+ Attend and participate at Investigation and CAPA Review Board (IRB/CRB).
+ Review and approve Investigation Protocol/Plan and Summary report.
+ Review and approve interim controls (Mitigation protocols) for continued production.
+ Review and approve Proactive Initiatives.
+ Review and approve Standalone actions.
+ Contribute to deviation management procedure improvement.
+ Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
Knowledge & Skills:
+ Must be skilled in planning and organizing, decision-making, and building relationships.
+ Able to effectively work in a dynamic / fast-paced environment.
+ Meets and exceeds all safety expectations and adheres to all BMS behaviors and values.
+ Must have knowledge on the review of deviation investigation and CAPA.
+ Must have knowledge on how to perform Root Cause Investigation.
+ Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.
+ Must partner with Investigation team for efficiently and timely completion of deviations.
+ Proactively seeks to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.
+ Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
+ Must be able to effectively prepare communications to management with clarity and a high level of accuracy.
+ Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, coaching other and analytical thinking.
+ Requires minimum direction to complete tasks; completes routine tasks as assigned.
+ Confident in making decisions for minor issues.
+ Contributes to goals within the work group.
+ Basic knowledge of aseptic manufacturing processes.
+ Works within cross functional teams to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.
+ Excellent verbal and written communication skills.
Basic Requirements:
+ Bachelor of Science in Physical Sciences, Engineering, related discipline. An equivalent combination of higher education and demonstrated experience will be considered.
+ Minimum of 5 years' experience in related cGMP environment: Cell Therapy, Pharmaceutical, Biologics, Medical Device operations.
+ Minimum of 4 years in QA/QC.
+ At least 1-2 years investigation experience.
Preferred Requirements:
+ Advanced degree, in a science area.
+ Knowledge of Cell Therapy (CT) operations (manufacturing, QC, packaging/shipping) is preferred.
+ Knowledge of LIMS and laboratory data analysis systems.
+ Support in Health Authority Inspections.
+ Ability to understand the manufacturing process of both Abecma and Breyanzi.
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: R1585940
Updated: 2024-10-08 02:16:51.295 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 Specialist, QA Operations Deviation role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.
Shift Available:
+ Wednesday - Saturday, Onsite Day Shift, 8AM - 6PM
Responsibilities:
+ Supports all activities for the Quality Operations Investigations group.
+ Review and approve Site operational investigation.
+ Review and approve Supplemental actions.
+ Review and approve Impact assessments or Product Quality Evaluation Approval.
+ Review and Approve Corrective and Preventive Actions (CAPA Plan, Action approval, Effectiveness Check (EC) Plan, EC execution Approval).
+ Participate in Audit and inspection including inspection readiness activities.
+ Attend and participate at Investigation and CAPA Review Board (IRB/CRB).
+ Review and approve Investigation Protocol/Plan and Summary report.
+ Review and approve interim controls (Mitigation protocols) for continued production.
+ Review and approve Proactive Initiatives.
+ Review and approve Standalone actions.
+ Contribute to deviation management procedure improvement.
+ Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
Knowledge & Skills:
+ Must be skilled in planning and organizing, decision-making, and building relationships.
+ Able to effectively work in a dynamic / fast-paced environment.
+ Meets and exceeds all safety expectations and adheres to all BMS behaviors and values.
+ Must have knowledge on the review of deviation investigation and CAPA.
+ Must have knowledge on how to perform Root Cause Investigation.
+ Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.
+ Must partner with Investigation team for efficiently and timely completion of deviations.
+ Proactively seeks to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.
+ Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
+ Must be able to effectively prepare communications to management with clarity and a high level of accuracy.
+ Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, coaching other and analytical thinking.
+ Requires minimum direction to complete tasks; completes routine tasks as assigned.
+ Confident in making decisions for minor issues.
+ Contributes to goals within the work group.
+ Basic knowledge of aseptic manufacturing processes.
+ Works within cross functional teams to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.
+ Excellent verbal and written communication skills.
Basic Requirements:
+ Bachelor of Science in Physical Sciences, Engineering, related discipline. An equivalent combination of higher education and demonstrated experience will be considered.
+ Minimum of 5 years' experience in related cGMP environment: Cell Therapy, Pharmaceutical, Biologics, Medical Device operations.
+ Minimum of 4 years in QA/QC.
+ At least 1-2 years investigation experience.
Preferred Requirements:
+ Advanced degree, in a science area.
+ Knowledge of Cell Therapy (CT) operations (manufacturing, QC, packaging/shipping) is preferred.
+ Knowledge of LIMS and laboratory data analysis systems.
+ Support in Health Authority Inspections.
+ Ability to understand the manufacturing process of both Abecma and Breyanzi.
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: R1585940
Updated: 2024-10-08 02:16:51.295 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