Quality Assurance Specialist

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Job description

Quality Assurance Specialist

Temp to Hire

Salary depended on qualifications and experience

M-F

8-5

The successful candidate will have experience supporting Quality documentation activities in an ISO 13485-compliant QMS, a minimum of 1-2 years of relevant industry experience, and will thrive in a dynamic, fast-paced working environment while contributing directly to our company culture and success. This position provides an opportunity to support the implementation and operation of a first-rate ISO 13485-compliant QMS for an industry-leading, agile genomics company with a quality-conscious customer base.

Duties

• Support Quality processes, including but not limited to change control, nonconformance and CAPA investigations, and internal audit
• Review and/or approve quality documents, records and reports including Nonconformance and CAPA investigation reports
• Change requests, product certificates of analysis, and manufacturing batch records
• Equipment calibration and qualification records
• Support the training management process to ensure compliance to training requirements, including training assignment and maintenance in training management tool
• Prepare and analyze routine QMS process metrics
• Support internal and external audits, as well as supplier audits

Education and Qualifications

Degree or higher in scientific or related field required. Minimum of 1-2 years of Quality Assurance experience, preferably in the biotechnology or medical device industry. Preferred ISO9001, ISO13485 or cGMP industry experience in Quality, Operations, or another related field

Required Knowledge and Abilities

A commitment to quality and a high level of self-motivation. Excellent verbal and written communications skills. Strong interpersonal skills and an ability to work as an effective member of a cross-functional team. Ability to work independently. The ability to multitask, perform consistently under pressure and work without supervision. Excellent organizational skills and outstanding attention to detail.

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.

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 interests-it's 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.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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.

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