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Kelly Services Clinical Quality Specialist in Rochester, New York

Clinical Quality Specialist

Kelly Services is seeking a Clinical Quality Specialist in Rochester, New York on site with our client medical device manufacturer.

This is a first shift position, full-time (40 hours/week) assignment. Duration is 14 months

Support the Clinical Quality Assurance function within Research and Development Operations with responsibility for managing audit program including audit schedules, audit records and CAPAs in the CQMS system, and conducting TMF audits ensuring clinical trials supporting pharmaceutical and medical device registrations are conducted in compliance with all applicable regulations.

Primary responsibilities include Manage audit schedules, audit records, and CAPA tracking.

Support auditees in developing effective, risk based corrective actions.

Support internal and regulatory inspections.

Authors/reviews summary reports, memos and standard operating procedures.

Conduct system, study, site and vendor audits.

Partner with key customer groups in clinical operations to develop and meet quality objectives. CQA team member responsible for enhancing the quality of clinical research trials through the support of clinical quality assurance initiatives.

Key Relationships - R D Clinical Operations, North America Region Global Product Surveillance Department, North America Region North America Quality ie. Compliance Quality Regulatory Affairs Clinical Quality Consultants and Contractors, External Regulatory Agencies

Requirements:

Minimum BS/BA in related field .Working knowledge of GxP regulations/ guidelines ICH, US FDA, ISO Strong computer skills Excellent communication verbal and written skills and ability to work effectively on teams. Excellent organization skills. Experience may include Minimum 2 years’ experience in related healthcare, medical device or pharmaceutical industry

Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Why Kelly Services? As a Kelly Services employee, you will have access to numerous perks, including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies

  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career

  • Access to more than 3,000 online training courses through our Kelly Learning Center

  • Weekly pay and service bonus plans

  • Group-rate insurance options available immediately upon hire*

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 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.

About Kelly ®

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/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.

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