Job Details

Specialist, Quality Assurance Deviation Investigator, Cell Therapy

Qlty Assurance Methods

icon-location-marker Bothell - WA - US
Posted 47 days ago Full_time R1548407

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The QSAT (Quality Science and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Jump located in Bothell, WA.  The Deviation Investigator on the QSAT 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 Quality Assurance team and a champion for quality priority principles and compliance within the Jump organization.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

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 4 years working within quality systems managing deviation and CAPA records.

  • 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.

  • Innovative, proactive, and resourceful; committed to quality and continuous improvement.

  • Ability to anticipate and mitigate challenges.

DUTIES AND 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

    • May participate on deviation governance teams, projects, and other initiatives

WORKING CONDITIONS (US Only):

  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.

  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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