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Bristol-Myers Squibb
Bothell, WA | Full Time
$76k-95k (estimate)
2 Weeks Ago
Senior Specialist, Quality Assurance Lot Disposition
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$76k-95k (estimate)
Full Time | Pharmaceutical 2 Weeks Ago
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Bristol-Myers Squibb is Hiring a Senior Specialist, Quality Assurance Lot Disposition Near Bothell, WA

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.

Our Quality Assurance and Compliance organization is pivotal in upholding quality standards within aseptic manufacturing, with core competencies in Microbiology and Chemistry. Our oversight extends across the entire product lifecycle, encompassing manufacturing, batch release, investigations, customer feedback management, document control, Quality Control testing, and diligent audits. Our team harnesses cutting-edge analytical and biologic test methods, leveraging state-of-the-art instrumentation and streamlined digital processes to meticulously affirm control.

The Senior Specialist of Quality Assurance (QA) Lot Disposition is a full-time position located at the BMS Cell Therapy Manufacturing Plant (Jump) in Bothell, WA. The primary focus for this role is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements. This position reports directly to the Senior Manager of Quality Assurance – Lot Disposition.

Shift Available:

  • The role will start out a Monday - Friday, Day Shift 8 hours, with a change to Sunday - Wednesday or Wednesday - Saturday, 10-hour days.

Responsibilities:

  • Conduct routine lot disposition activities for finished drug products and incoming raw materials by ensuring all relevant documentation associated with a lot are accounted for, completed, and approved under cGMP standards.

  • Review and approve the QC documentation related to each lot (Certificate of Analysis and QC testing data, including EM and analytical data).

  • Perform the review of lot genealogy for all raw materials and components used in each drug product lot to ensure they are approved and released using the electronic system (MES - Manufacturing Execution System or ERP – Enterprise Resource Planning System).

  • Conduct the drug product lot disposition process and ensure the dosage assignment is reviewed and approved by the appropriate individuals.

  • Collaborate with stakeholders and management and communicate lot disposition status; monitor progress and issue status reports.

  • Assemble and review Quality system documents such as, deviations, batch production records, test methods, specifications, and controlled forms associated with each lot for disposition.

  • Create and revise relevant Standard Operating Procedures (SOP), Work Instructions (WI), Forms, and Reference Documents as needed.

  • Support internal and external audit activities, batch record reviews, change controls, and other QA department needs as identified by management. Champion and foster a positive and successful quality culture, aligned with BMS' existing culture.

  • Support continuous improvement projects to improve efficiency of the manufacturing and related business processes.

  • Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Knowledge & Skills:

  • Knowledge of cGMP regulations and FDA guidance’s applicable to biologics and cell therapy.

  • Detail oriented with strong good documentation practices expertise.

  • Direct experience with lot disposition supporting the manufacturing, testing, disposition, and distribution of cGMP products.

  • Demonstrated excellence in written and verbal communication.

  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

Basic Requirements:

  • Bachelor’s degree in life or physical science discipline or an equivalent combination of education and work experience.

  • 4 years of cGMP experience required.

  • 2 years of Quality experience required (either QA, QC or a combination).

Preferred Requirements:

  • Lot disposition experience.

  • QMS experience.

  • Technical writing skills.

The starting compensation for this job is a range from $75,000 to $95,000, plus incentive cash and stock opportunities (based on eligibility). 

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 
Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, 
pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). 
Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like 
tuition reimbursement and a recognition program.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$76k-95k (estimate)

POST DATE

04/10/2024

EXPIRATION DATE

04/17/2024

WEBSITE

bms.com

HEADQUARTERS

NEW YORK, NY

SIZE

15,000 - 50,000

FOUNDED

1858

TYPE

Public

CEO

GIOVANNI CAFORIO

REVENUE

$10B - $50B

INDUSTRY

Pharmaceutical

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About Bristol-Myers Squibb

Bristol-Myers Squibb is a biopharmaceutical firm that discovers, develops and delivers medicines for patients prevail over serious diseases.

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