Job Description

JOB TITLE: QUALITY ASSURANCE SPECIALIST

LOCATION: BOTHELL, WA 98021

DURATION: 12+ MONTHS (POSSIBILITY OF EXTENSION)

JOB DESCRIPTION:   

• Need 3 contractors
• The QSAT team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Manufacturing Plant located in Bothell, WA.
• The QSAT Specialist Approver position is an individual contributor role responsible for providing QA oversight and approving deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations.
• This position will be responsible for operating cross-functionally, reviewing necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from recurring.
• This person will be a key player in the Jump QSAT team and a champion for quality priority principles and compliance within the Jump organization.

EDUCATION:

• Bachelor’s degree in relevant Science or Engineering discipline or equivalent experience.

EXPERIENCE:

• 3+ years of experience in execution of deviation investigations, experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry; experience in the cellular therapy field is preferred.
• Minimum of 2 years working within quality systems managing deviations and CAPA.
• Experience with use of complex Root Cause Analysis (RCA) tools and methodologies.

DUTIES:

• Actively partners with Investigators to help drive on-time phase completion, including deviation closure by the original due date.
• Immediately upon assignment of an investigation to an investigator, partners with the lead investigator and investigation team to help define and align on 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, partners with the investigation/CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
• Helps ensure 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.
• Participates on GEMBAs to identify failure modes and seek further understanding of the deviations when needed
• Ensures HOP (Human and Organizational Performance) principles are applied to investigations

USES BOTH SOFT-SKILLS AND TECHNICAL SKILLS TO HELP 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 reviews deviations to ensure they are thorough, accurate, and complete understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase demonstrates correct assignment of classifications and understands the requirements for each understands the importance and impact of lot association within deviations and the relation to product disposition ensures the necessary data to support containment activities and impact assessments have been provided ensures all necessary supporting evidence is attached to the electronic deviation and that all attachments are referenced in the record ensures investigations and root cause analyses are commensurate to the event being investigated understands multiple RCA tools and when, where, and how they should be applied reviews deviation reports for good technical writing skills actively coaches and mentors’ investigators through the review and approval processes.

PARTICIPATES ON DEPARTMENT-SPECIFIC TREND DEVIATIONS TO:

• Assess trend details to ensure accuracy and alignment across the team.
• Participate in 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.
• Maintains and routinely communicates an up-to-date dashboard of department-specific CAPA to show current status, escalate issues, provide mitigation plans, and request additional support.
• Understands appropriate assignment of classifications and requirements for each.
• May participate on deviation governance teams, projects, and other initiatives.

ABOUT ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK CONSULTING IS AN EQUAL OPPORTUNITY EMPLOYER. WE CELEBRATE DIVERSITY AND ARE COMMITTED TO CREATING AN INCLUSIVE ENVIRONMENT FOR ALL ASSOCIATES.

CONTACT:

FULL NAME: SAVITA KHASHU

EMAIL ID: SAVITAK@ASKCONSULTING.COM

PHONE: 470-483-1052