Senior Specialist, MSAT Investigations-EM

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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 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

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.
• Preferred Experience with microbiological techniques and/or environmental monitoring
• Experience authoring deviation and CAPA records.
• 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.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to anticipate and mitigate challenges.

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 decided based on demonstrated experience.

For more on benefits, please visit our BMS Careers site.

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.

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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.

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/

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