Bristol Myers Squibb Company

Deviation Reviewer/Approver, QA Specialist

Location
Bothell, WA, United States
Posted
Sep 10, 2020
Ref
R1527986
Required Education
Bachelors Degree
Position Type
Full time
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 and CAPA records through the electronic quality record management system at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The QSAT Deviation Reviewer/Approver is an individual contributor role responsible for the review and approval of events classified as Notice of Event, Minor, Major, and Critical deviations. Management of deviation and CAPA records will include:
  • cross-functional collaboration to ensure the proper root cause and corrective actions have been identified
  • ensuring the written report contains the technical merit and completeness according to regulatory expectations
  • coaching customers on navigation within the deviation management electronic system

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:
  • Bachelor or Master's degree in Life Science or Engineering discipline.

Experience
  • 5+ years of experience in execution and/or approval of deviation investigations.
  • Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology / pharmaceutical industry; experience in protein biologics or cellular therapy field is preferred.
  • Experience in a Quality Assurance or technical MSAT role within a GMP manufacturing organization.
  • Experience with using complex Root Cause Analysis (RCA) tools and methodologies.
  • Experience with using Quality Risk Management principles.
  • Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.

Knowledge, Skills, and Abilities
  • Expertise in GMP compliance and FDA/EMA regulations.
  • Demonstrated excellence in technical writing.
  • Ability to communicate effectively to key stakeholders.
  • 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.
  • Ability to coach/mentor junior level colleagues working within deviation and CAPA management systems.

DUTIES AND RESPONSIBILITIES:

Key Responsibilities
  • Actively coordinates with deviation owners 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 the investigation team (Deviation Investigator(s), 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 required, provides guidance to the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements
  • Collaborates with cross-functional investigation teams on department-specific trend deviations. Provides guidance to the investigation team for performing a deep-dive analysis of department-specific trends, to include:
    • Assessing trend details to ensure accuracy and alignment across the team
    • Facilitating in-depth root cause analysis to determine additional process and system failure modes
    • Evaluating previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
    • Determining if previous identified CAPA are sufficient to reduce the trend by defined targets
  • Leads/Represent Quality Operations during GEMBAs, and supports interviews of personnel closest to the work to identify failure modes and seek further understanding of the deviations
  • Evaluates the application of 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
    • Ensures deviations 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 each tool
    • 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

BMSCART

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.