Senior Specialist, MSAT Bothell WA

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Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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: 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 BMS Bothell WA. The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating No Impact 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 environmental monitoring (EM) and personnel monitoring (PM) related investigations and determine the associated corrective action to prevent the deviation from reoccurring

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

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 EM/PM trend deviations. Leads investigation team to perform deep-dive analysis of EM/PM 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
May participate on deviation governance teams projects and other initiatives