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13 days old

Quality Specialist III

Kelly Services
Carlsbad, CA 92008
**Quality Specialist III**


Partner with GSS, R D, Product Management and Site Manufacturing on GSS quality investigations. May support internal audits ensuring compliance to applicable international and national standards, regulations, and guidelines. Create, track and present GSS quality escalation updates/status, milestones, issues, actions, and report outs to stakeholders, site, divisional and group leadership. Drive GSS quality escalations and CAPA s to resolution and completion Work with a customer centric mindset to ensure GSS quality escalations and CAPA s are aligned with customer expectations internal external and delivered accordingly. Work collaboratively and build effective relationships with critical stakeholders, contractors, etc. to enable timely resolutions to GSS quality investigations and CAPA s How will you get here? 3-5 years managing quality investigations and CAPA s Excellent understanding of regulations and standards such as 21 CFR 820, ISO 13485, ISO 9001, or similar standards/regulations in support of a Service Organization. Demonstrates a sense of urgency, contagious optimism and a can do attitude. Results driven with a strong capability to influence without authority Demonstrated skills in project management Must have a good knowledge of the inner workings of a large company. Good technical writing skills, excellent time management skills and ability to work independently required. Solutions oriented with a forward focused mentality; see problems coming and develop strategic solutions, with creativity in problem solving Proven ability to effectively develop, communicate, and gain support cross functionally and with a wide range of stakeholders. Excellent judgment and creative problem-solving skills, excellent interpersonal skills, organizational skills, written and oral communication skills Required Experience Bachelor s Degree is required Biological sciences or related degree ; advanced degree is a plus 3-5 years of experience investigating complaints and CAPA s in an FDA regulated industry drugs, biologics, medical devices, or related industry.


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**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: 2021-10-08 Expires: 2021-11-08

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Quality Specialist III

Kelly Services
Carlsbad, CA 92008

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