What are the responsibilities and job description for the Sr. Specialist, QA Operations position at Bristol Myers Squibb?
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 .
Position Sr. Specialist, Quality Assurance Operations
Location Warren, NJ
The Sr. Specialist, QA Operations is responsible for quality oversight of Cell Therapy Development Operations activities in accordance with BMS policies, standards, procedures, and Global cGMP requirements. Functional responsibilities include On-Site coverage/participation in QA Shop Floor and Warren Site Walkthrough activities, Label Printing and Issuance of finished drug product and shipping labels, Event Triage including Deviation and CAPA QA Review and Approval, Packout oversight and performing market release, ensuring accurate and timely review and maintenance of clinical manufacturing GMP/batch related documentation and procedures.
This position will report to Sr. Manager, QA Operations.
VETERAN
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/ 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.
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 .
Position Sr. Specialist, Quality Assurance Operations
Location Warren, NJ
The Sr. Specialist, QA Operations is responsible for quality oversight of Cell Therapy Development Operations activities in accordance with BMS policies, standards, procedures, and Global cGMP requirements. Functional responsibilities include On-Site coverage/participation in QA Shop Floor and Warren Site Walkthrough activities, Label Printing and Issuance of finished drug product and shipping labels, Event Triage including Deviation and CAPA QA Review and Approval, Packout oversight and performing market release, ensuring accurate and timely review and maintenance of clinical manufacturing GMP/batch related documentation and procedures.
This position will report to Sr. Manager, QA Operations.
- Note The work week for this position is Wednesday-Sunday.
- Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
- Participate in Shop Floor and Quality Check Walkthrough programs.
- Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations.
- Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints.
- Revise department SOPs, as well as Review and QA Approval of CTD SOPs.
- Perform review /approval of executed batch records and Chain of Identity verification.
- Responsible for ERP Material Status Changes of production/drug product.
- Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
- Supports Risk Assessments/projects as required by senior management.
- B.S. scientific discipline or relevant college / university degree preferred.
- Minimum 5 years cGMP work experience with minimum 2 years of Quality experience.
- Equivalent combination of education and experience acceptable.
- Strong knowledge of cGMP Quality and Compliance principles required.
- Clinical and Phase appropriate experience preferred.
- Strong cross-functional collaboration experience required.
- Must have advanced knowledge and Quality experience with cGMP manufacturing US and global requirements.
- Must possess an independent mindset and 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.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Work is self-directed yet collaborative with CTD counterparts.
- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
- Seeks management guidance on complex issues.
- Follows established procedures and performs work as assigned and develops procedures as needed.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Proposes solutions for complex issues and works with management to resolve.
- Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy.
VETERAN
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/ 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.
