layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Specialist, MSAT Investigations at Bristol Myers Squibb

· 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

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.
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 adastaffingsupport@bms.com . 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 TAEnablement@bms.com 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

Senior Specialist, MSAT Investigations

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