The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Client located in Bothell, WA.
The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating No Impact, 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 Client MSAT team and a champion for quality priority principles and compliance within the Client organization.
Minimum of Bachelor's degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.
5+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
Minimum of 2 years working within quality systems managing deviation and CAPA records.
Experience authoring 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.