- Expiry Date: 03 February 2022
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 Juno Manufacturing Plant (JuMP) located in Bothell, WA. This position will be responsible for operating cross-functionally and facilitating the timely approval and closure of deviation records (excluding Major and Critical deviations).
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.
Minimum of Bachelors degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.
2+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
Minimum of 1 year working within quality systems managing 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:
Experience in GMP compliance and FDA/EMA regulations.
Demonstrate proficiency in use of MS Excel and Teams (or related programs).
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.
Excellent written and verbal communication, including ability to anticipate and mitigate challenges.
DUTIES AND RESPONSIBILITIES:
Builds processes to approve and close NOEs by the end of the shift (95% within 24 hours)
Builds and manages a real-time process to establish feedback to departments on preventable deviations for awareness and documentation.
Collaborates with stakeholders to develop mitigation plan to prevent reoccurrence.
Establishes system for providing feedback to initiators to continue to drive RFT
Establishes targets for turnaround times for requests from Investigators and QA Reviewers / Approvers to Operations
Point of contact for all deviations in all departments at the point of observation and/or discovery
Follows the classification decision tree and procedures to determine initial assessment for classification (batch comment, NOE, minor / major, critical), escalates real-time when needed to ensure real-time classifications are made
Completes the QA Assessment by the end of the shift (no later than 24 hours from the original observation of the event) for all NOEs, acts as deviation facilitator for all functional areas as needed.
Ensures IDAs and QA Assessments are completed in a timely manner, acts as deviation facilitator for all functional areas as needed
Identifies owners for IDAs, QA Assessments, and Investigations
Assesses impacted lots and materials accurately, references CAPA as needed
Point of contact for the Investigators and QA Reviewers / Approvers when further information or clarification is needed
Coaches the area owner on initiation of the deviation in the deviation system
Coaches the area owner on completion of the IDA for NOEs
Provides timely, complete and accurate information
Helps bridge communication and relationships between QA Ops OTF and QSAT
Ensures timely delivery and documentation of deviation feedback to operations (RFT, preventable deviations, trends, etc)
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
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
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