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18 days old

Quality Assurance Specialist - Cell Therapy

Kelly Services
Bothell, WA 98021
ROLES AND RESPONSIBILITIES


+ 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


EDUCATION/EXPEREINCE REQUIREMENTS


+ Bachelors degree in relevant Science or Engineering discipline or equivalent 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.

+ Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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/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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-14 Expires: 2022-10-15

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Quality Assurance Specialist - Cell Therapy

Kelly Services
Bothell, WA 98021

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