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GMP Quality Assurance Coordinator

Company: University of North Carolina at Chapel Hill
Location: Chapel Hill
Posted on: July 3, 2019

Job Description:

Posting Information Position Information Position Type Permanent Staff (EHRA NF) Department Lineberger Compr Cancer Center-426801 Working Title GMP Quality Assurance Coordinator Appointment Type EHRA Non-Faculty Position Posting Category Research Professionals Salary Range Dependent on Qualifications/Experience Full Time/Part Time? Full-Time Permanent Hours per Week 40 Vacancy ID NF0003845 Position ID 20034202 Posting Open Date 06/24/2019 Application Deadline 07/08/2019 Open Until Filled No Proposed Start Date 09/01/2019 Position Summary The GMP Quality Assurance Coordinator will be responsible to monitor, develop, and drive quality assurance initiatives. Ensure that systems are safe, effective, appropriate, and compliant with applicable regulations and standards. Be accountable for quality and integrity of data entered into records and reports generated. Develop and regularly process quality control reports and queries to ensure Data Standards are maintained and Policies and Standard Operating Procedures are followed. Measure the quality of processes and outcomes to evaluate the impact of improvement efforts and identify improvement opportunities. Will be an integral part of assigned programs and teams. Educational Requirements Masters of Science or Masters of Technology or a Bachelor of Science in a related field with a certification in SBB or ASQ. Qualifications and Experience At least 6 years in a related field (clinical laboratory, biologic research laboratory, biologic or pharmaceutical industry), related quality and regulatory experience required, experience with FDA regulations or Foundation for the Accreditation of Cellular Therapies (FACT). Demonstrated attention to detail and accuracy, understanding of quality and regulatory matters, including day-to-day working competence, demonstrated experience with data retrieval and relational database systems, understanding of health care and clinical research operations. Demonstrates excellent written, verbal, interpersonal, communication, and organizational skills. Preferred prior lab experience. Equal Opportunity Employer The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran. Special Instructions Quick Link http://unc.peopleadmin.com/postings/164883 Department Contact Information Department Contact Name and Title Nick McBride, HR Consultant Department Contact Telephone or Email nick_mcbridemed.unc.edu Office of Human Resources Contact Information If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employmentunc.edu Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status. Applicant Documents Required Documents Curriculum Vitae / Resume Cover Letter Optional Documents Certification/licenses List of References Supplemental Questions Required fields are indicated with an asterisk (). Please select the response below that describes your level of education that best or mostly closely satisfies the education requirements for this position. Bachelor's degree in required discipline(s) listed or related field Bachelor's degree in any field/discipline Master's degree or Doctorate degree in required discipline(s) listed or related field Master's degree or Doctorate degree in any field/discipline None of the above Describe your experience with regulatory submissions to the FDA. (Open Ended Question) Please describe your previous experience with Quality Control and Quality Assurance responsibilities. (Open Ended Question)

Keywords: University of North Carolina at Chapel Hill, Chapel Hill , GMP Quality Assurance Coordinator, Other , Chapel Hill, North Carolina

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