Specialist, Quality Assurance - Patient Material Logistics
Working with UsChallenging.
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.
The Senior Specialist, Quality Assurance - Patient Material Logistics (QA-PML), is responsible for quality activities supporting Manufacturing Shared Services - Patient Material Operations (MSS-PMO) in the receipt of apheresis from domestic patient collection sites, PBMC (Peripheral Blood Mononuclear Cells) from international Make 1 facilities, and shipping cryopreserved drug product to patient infusion sites in accordance with Bristol-Myers Squibb policies, standards, procedures and Global cGMPs.
Shift Available:
Sunday - Wednesday, Onsite Day Shift (6 a.
m.
- 4:
30 p.
m.
)
Responsibilities:
Oversee Apheresis, PBMC and CMAT receiving and Cryopreserved Drug Product (CDP) Shipping for both clinical and commercial lots of two different product lines.
Build and maintain relationships with MSS-PMO, Warehouse, Quality, and Manufacturing Operations, as well as Supply Chain, Materials Management, Facilities and other departments to effectively accomplish tasks, make improvements, and resolve issues.
Support or work with other departments in reviewing, approving or providing input to deviations, change controls, procedures, investigations, CAPAs and work orders.
Ensure compliance with applicable procedures and requirements for storage, documentation, material handling, and safe equipment operation.
Support quality processes, including material disposition, material storage and handling requirements, change controls, product complaints, deviations, investigations, and CAPA management.
Provide QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner, including leading or attending triage meetings.
Routinely recognize and resolve quality issues, inform management of proposed solutions, and seek management guidance on complex issues.
Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Use electronic quality management systems (QMS) to document deviations and actions.
Use electronic document management systems (DMS) to review, revise or approve SOPs and/or other controlled documents.
Use ERP systems to change lot status or perform other data entry.
Review executed records for documentation completeness and accuracy per ALCOA+.
Review and approve patient material discards and transfers using QMS and ERP systems.
Contribute or drive goals within the work group.
Must be available for weekend and off-shift hours.
Performs other assigned tasks as required to meet company or department objectives.
Knowledge & Skills:
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 the immediate team and with cross-functional teams to achieve objectives.
Ability to follow technical reports or data that affects quality of materials, such as environmental/temperature tracking.
Must have sound knowledge and experience in FDA-regulated operations and processes, as well as knowledge of US and global cGMP requirements.
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.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Confident in making decisions for non-routine issues.
Skilled in developing and writing procedures.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
Able to apply critical thinking and logic to present problems and solutions verbally or in writing with clarity, attention to detail, and accuracy.
Excellent verbal and written communication skills.
Must possess an independent mindset as work is self-directed.
Must be collaborative and team oriented.
Basic Requirements:
Bachelor's degree required.
Equivalent combination of education and experience acceptable.
Minimum of 1 year work experience in the pharmaceutical, CAR T, or similar industry using GXP.
Minimum of 1 year work experience within QA or QC.
Knowledge of Quality Management Systems.
Working Conditions:
Work is performed in a combination of CNC space, NC space and office environments, with standard office equipment available and used.
Work may be performed seated but will require standing and walking for up to 50% of the time.
Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
BMSCART, #LI-OnsiteIf 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 email protected .
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Analytical Attention To Detail Business Process Improvement Clinical Works Coaching And Mentoring Communication Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
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on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3v4z86c9nb9z7fwskf', 'ExternalApply-j3v4z86c9nb9z7fwskf'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
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.
The Senior Specialist, Quality Assurance - Patient Material Logistics (QA-PML), is responsible for quality activities supporting Manufacturing Shared Services - Patient Material Operations (MSS-PMO) in the receipt of apheresis from domestic patient collection sites, PBMC (Peripheral Blood Mononuclear Cells) from international Make 1 facilities, and shipping cryopreserved drug product to patient infusion sites in accordance with Bristol-Myers Squibb policies, standards, procedures and Global cGMPs.
Shift Available:
Sunday - Wednesday, Onsite Day Shift (6 a.
m.
- 4:
30 p.
m.
)
Responsibilities:
Oversee Apheresis, PBMC and CMAT receiving and Cryopreserved Drug Product (CDP) Shipping for both clinical and commercial lots of two different product lines.
Build and maintain relationships with MSS-PMO, Warehouse, Quality, and Manufacturing Operations, as well as Supply Chain, Materials Management, Facilities and other departments to effectively accomplish tasks, make improvements, and resolve issues.
Support or work with other departments in reviewing, approving or providing input to deviations, change controls, procedures, investigations, CAPAs and work orders.
Ensure compliance with applicable procedures and requirements for storage, documentation, material handling, and safe equipment operation.
Support quality processes, including material disposition, material storage and handling requirements, change controls, product complaints, deviations, investigations, and CAPA management.
Provide QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner, including leading or attending triage meetings.
Routinely recognize and resolve quality issues, inform management of proposed solutions, and seek management guidance on complex issues.
Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Use electronic quality management systems (QMS) to document deviations and actions.
Use electronic document management systems (DMS) to review, revise or approve SOPs and/or other controlled documents.
Use ERP systems to change lot status or perform other data entry.
Review executed records for documentation completeness and accuracy per ALCOA+.
Review and approve patient material discards and transfers using QMS and ERP systems.
Contribute or drive goals within the work group.
Must be available for weekend and off-shift hours.
Performs other assigned tasks as required to meet company or department objectives.
Knowledge & Skills:
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 the immediate team and with cross-functional teams to achieve objectives.
Ability to follow technical reports or data that affects quality of materials, such as environmental/temperature tracking.
Must have sound knowledge and experience in FDA-regulated operations and processes, as well as knowledge of US and global cGMP requirements.
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.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Confident in making decisions for non-routine issues.
Skilled in developing and writing procedures.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
Able to apply critical thinking and logic to present problems and solutions verbally or in writing with clarity, attention to detail, and accuracy.
Excellent verbal and written communication skills.
Must possess an independent mindset as work is self-directed.
Must be collaborative and team oriented.
Basic Requirements:
Bachelor's degree required.
Equivalent combination of education and experience acceptable.
Minimum of 1 year work experience in the pharmaceutical, CAR T, or similar industry using GXP.
Minimum of 1 year work experience within QA or QC.
Knowledge of Quality Management Systems.
Working Conditions:
Work is performed in a combination of CNC space, NC space and office environments, with standard office equipment available and used.
Work may be performed seated but will require standing and walking for up to 50% of the time.
Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
BMSCART, #LI-OnsiteIf 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 email protected .
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Analytical Attention To Detail Business Process Improvement Clinical Works Coaching And Mentoring Communication Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
external-apply-email-saved').
on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3v4z86c9nb9z7fwskf', 'ExternalApply-j3v4z86c9nb9z7fwskf'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
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