Senior Specialist, MSAT Investigations

Bristol Myers Squibb; Bothell (WA); On-site; USD 91,000 - 110,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, MSAT Investigations in Bothell, WA to lead deviation investigations ensuring regulatory compliance and timely CAPA closure. The role collaborates with QA Reviewer/Approver, SMEs, and stakeholders to define plans and gather data for root-cause analyses.

The position emphasizes cross-functional teamwork, rigorous documentation, and effective communication to drive quality improvements in manufacturing and laboratory investigations within the

Qualifications

• Bachelor’s degree in relevant Science or Engineering is required.
• 5+ years of relevant cGMP experience, FDA/EMA regulation preferred.
• Minimum of 2 years working with quality systems managing deviation and CAPA records.

Responsibilities

• Actively manages deviations to achieve RFT and on-time phase completion, including deviation closure by the original due date.
• Partners with investigation team on definition and alignment of the investigation plan, required data, and timing for completion.
• Facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
• Ensures smooth transition of CAPA to the owning department SME and timely implementation.
• Leads GEMBAs and interviews personnel to identify failure modes and gain understanding of deviations.
• Applies Human and Organizational Performance (HOP) principles to investigations.
• Demonstrates teamwork and communication with internal and external customers.
• Understands the deviation and CAPA processes including all phases and asset-lot relationships.
• Attaches all necessary supporting evidence to deviations and ensures referenced attachments.

Skills

GMP compliance

Cross-functional collaboration

Written and verbal communication

Root cause analysis

CAPA management

Data collection

Education

Bachelor’s degree in relevant Science or Engineering

Job description

Position summary

The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating Notice of Event, Minor, Major, and Critical deviations to determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from reoccurring.

This person will be a key player in the JuMP MSAT team and a champion for quality priority principles and compliance within the JuMP organization.

Duties/Responsibilities

Key Responsibilities

• Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date
• Immediately upon assignment of an investigation, partners with their investigation team (QA Reviewer/ Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion. Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA
• When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements
• Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure
• Owns and investigates department-specific trend deviations. Leads investigation team to perform deep-dive analysis of department-specific trends, including to:
• Assess trend details to ensure accuracy and alignment across the team
• Facilitate in-depth root cause analysis to determine additional process and system failure modes
• Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
• Determine if previous identified CAPA are sufficient to reduce the trend by defined targets
• Leads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations
• Applies HOP (Human and Organizational Performance) principles to investigations
• Uses both soft-skills and technical skills to drive the deviation and CAPA processes:
• Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
• Seeks to understand, demonstrates humility, and shows curiosity for learning
• Completes deviations that are thorough, accurate, and complete
• Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase
• Understands appropriate assignment of classifications and requirements for each
• Understands the importance and impact of lot association within deviations and the relation to product disposition
• Captures the necessary data to support containment activities and impact assessment
• Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record
• Performs investigations and root cause analyses that are commensurate to the event being investigated
• Understands multiple RCA tools and when, where, and how to apply them
• Utilizes good technical writing skills
• Contacts vendor as needed to complete investigations in a timely manner

Qualifications

Education

• Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.

Experience

• 5+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
• Minimum of 2 years working within quality systems managing deviation and CAPA records is preferred.
• Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.

Knowledge, Skills, and Abilities

• Expertise in GMP compliance and FDA/EMA regulations.
• Demonstrate excellence in written and verbal communication.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Ability to Anticipate and mitigate challenges
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Bothell - WA - US: $90,660 - $109,860

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. (https://careers.bms.com/life-at-bms/ways-of-working/)

Supporting People with Disabilities

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 [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

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

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607303 : Senior Specialist, MSAT Investigations

Req Number

R1607303

Location

Bothell - Washington - US

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.