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27 days old

QA Associate (West Hills, CA)

Kelly Services
West Hills, CA 91307
Quality Assurance Associate (West HIlls, CA)


Pay Rate: $53.00/hour


Job Description:


This position is responsible for compliance to the Corrective and Preventative Action CAPA process, and to applicable Medical Device and IVD regulations and requirements by serving as a subject matter expert in providing guidance to CAPA owners, and working closely with CAPA Review Board CRB members in the administration of CAPA activities and the rigorous assessment of CAPA documentation.


Position Responsibilities:


Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with the CAPA process, FDA regulations, ISO 13485, and Medical Device and IVD requirements through the review of CAPA records at critical phases.Provide guidance, support and mentorship to CAPA owners regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.


Support CRB and senior leadership with metrics and reporting on critical aspects regarding the health of the CAPA process.


Participate and coordinate CRB activities and perform CAPA Specialist role throughout the site.


Support the continuous improvement of CAPA procedures, CAPA software, and CAPA training programs.Provide guidance in interpreting governmental regulations, agency guidelines and followl policies in general and specific to CAPA to assure compliance.Support internal and external audits and inspections for CAPA records and processes and other roles as needed.Perform other related duties as assigned.


Basic Qualifications:


Bachelor's degree and 5+ years or Master s degree with 2+ years in a quality, manufacturing, or leadership role preferably in managing the CAPA process.


Desired/Preferred Qualifications:


Experience working with CAPA, complaints, and nonconformancesExperience in medical device, pharmaceutical, IVD and/or a comparable regulated environmentInfluence management skills; ability to work constructively across all functions of the organization as well as with external customers, notified bodies, regulatory agencies, and competent authorities


Project management skills


CAPA documentation systems experience e.g. CATSWeb, MasterControl, Trackwise,, etc. Experience reviewing CAPA, complaint, nonconformance documentation preferably as an independent reviewer Strong written and verbal communication skillsAbility to educate people in the CAPA program


Experience with quality tools and process improvement techniquesKnowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniquesStrong analytical and decision making skills


Understanding of FDA regulations


**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** **** **?**


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/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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-04-29 Expires: 2022-05-30

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QA Associate (West Hills, CA)

Kelly Services
West Hills, CA 91307

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