Contract QA Sr. Specialist, Deviation Investigator (Remote)

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Job description

Contract QA Sr. Specialist, Deviation Investigator (Remote)

Kelly Services is currently seeking Contract QA Sr. Specialist to run Deviation and Investigations for our global sponsor client on a 6 month contract.

• Location: Remote work however it would be beneficial for candidate to come on site (Bothell, WA) for orientation.
• Contract: 6 month contract offering benefits and work from home options

Scope: 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 Juno Manufacturing Plant (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.

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.

?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
  • Contact vendor as needed to complete investigations in a timely manner
  • May participate on deviation governance teams, projects, and other initiatives

Desired Experience:

• 7+ 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.
• Experience with use of complex Root Cause Analysis (RCA) tools and methodologies.
• Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
• Background in Protein Biologics or Cell Therapy Manufacturing is strongly recommended.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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