1+ months

QA Associate, QSAT Deviation Facilitator

Kelly Services
Bothell, WA 98021
Quality Assurance Associate - QA Associate I

Job Title: QA Associate, QSAT Deviation Facilitator

Shift: Sunday-Wednesday, 10 am - 8:30 pm, reports into the QSAT Manager

Shift: Wednesday-Saturday, 10 am - 8:30 pm, reports into the QSAT Manager


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.

Experience 2+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.

Minimum of 1 years 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 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

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.

**Why Kelly** **** **?**

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 interestsits 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.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-23 Expires: 2020-11-30

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QA Associate, QSAT Deviation Facilitator

Kelly Services
Bothell, WA 98021

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