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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 .

The Senior Specialist for the QA Sterility Assurance group is an individual contributor role responsible for the quality oversight of the site contamination control strategy, including Environmental Monitoring (EM), EM investigation program, support for contamination events, and quality risk assessments.

Duties/Responsibilities

• Quality oversight and support for programs such as cleaning and disinfection, gowning, access and flow, facility modifications, qualifications, disruptions, and shutdowns.

• Quality oversight and support of Environmental Monitoring Excursion Investigation Program, including CAPA creation and management.

• Quality oversight and support for contamination investigations/CAPAs/effectiveness checks associated with, but not limited to environmental monitoring excursions, aseptic personnel qualification, aseptic operations, classified areas, utilities, and QC Microbiology.

• Author EM and Utility trending reports at designated frequencies (i.e., quarterly, and annually).

• Creation and Revision of technical documents (SOPs, Risk Assessments, Reports, Protocols, etc.).

• Author impact assessments for moderate level site change controls, as requested.

• Participate in quality risk assessments associated with contamination control program, owned by sterility assurance or stakeholder departments. Assist with facilitation or serve as risk champion for department owned risk assessments.

• Support the Contamination Control Strategy, Quality Initiatives, and Identify continuous improvement opportunities. Support execution of site/team improvement goals and projects related to environmental and contamination control programs.

• Routinely recognize and resolve Quality issues; propose solutions for complex issues and work with management to resolve.

• Ability to collaborate with cross-functional team members on projects related to contamination control program. Build and maintain strong relationships with partner departments.

• Lead meetings and represent department at cross-functional meetings sharing data and knowledge across team.

• Maintain compliance with assigned learning plan.

• Support internal and external inspections as required.

• Perform other tasks as assigned.

Reporting Relationship

• This position reports to the Associate Director of Quality Assurance Sterility Assurance at Cell Therapy Manufacturing: Bothell.

Qualifications

Specific Knowledge, Skills, Abilities:

• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.

• Advanced knowledge and experience with cGMP manufacturing, Quality and Compliance.

• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.

• Ability to interpret data and results, understand problems with few variables and critically assess and provide feedback on proposed solution and required documentation.

• Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.

• Ability to work in a fast-paced team environment and balance workload based on changing priorities.

• Detail oriented and task focused with ability to meet deadlines and prioritize work.

• Able to work across functional groups and teams to ensure requirements are met.

• Self-motivated and contribute to a positive team environment.

• Confident in making decisions for non-routine and minor issues.

• Curious and ability to think critically to create innovative solutions.

• Proficient computer skills with knowledge of several digital tools like MS Office, Quickbase, Smartsheets, and ability to learn new software applications.

Education/Experience:

• Bachelor's Degree in Microbiology, Biology, STEM, or related science and 4+ of relevant cGMP experience, or equivalent combination of education and experience.

• Experience in Quality Control function in a cGMP manufacturing operation.

• Experience in FDA/EMA or similar regulation in biotechnology or cellular therapy field is preferred.

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

• Demonstrated experience with electronic systems and databases.

• Demonstrated experience with root cause analysis and risk management tools such as 5-WHY, Human Error Prevention, Fishbone Analysis, FMEA, PrHA, etc.

The starting compensation for this job is a range from $82,000 - $102,000, plus incentive cash and stock opportunities (based on eligibility).

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

For more on benefits, please visit our BMS Careers si te.

Eligibility for specific benefits listed in our careers site may vary based on the job and location.

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.

BMSCART

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: R1583889

Updated: 2024-09-10 05:16:47.115 UTC

Location: Bothell-WA

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.