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Quality Control Manager (#15970)

Cherokee Nation Operational Solutions (CNOS) provides a complete line of medical equipment and supplies along with innovative office products and services to businesses and health care facilities throughout North America. Wholly owned by Cherokee Nation, Cherokee Nation Operational Solutions is part of the Cherokee Nation Businesses’ family of companies.

For more company information, visit our site at http://cherokee-os.com/Pages/Home.aspx    

Seeking a Quality Control (QC) Manager to join a team of scientists and project managers supporting an ongoing in vitro diagnostics (IVD) program within the CDC National Center for Immunization and Respiratory Diseases, Influenza Division.  This program includes sustaining existing IVDs already FDA-cleared and manufactured as well as supporting development and manufacture of novel IVDs and Research Use Only (RUO) products.

The selected candidate will work at the Centers for Disease Control and Prevention (CDC) Roybal Campus located in the Atlanta Metropolitan Area.

 

Essential Duties and Responsibilities

  • Coordinate QC operations for testing and release of multiple in-vitro diagnostic (IVD) products and Research Use Only (RUO) products under a designated CDC Quality System and where applicable, compliant with FDA regulations
  • Coordinate with program managers in the development and execution of QC testing according to production plans for multiple products
  • Work with program managers and scientists to expand laboratory QC capabilities as appropriate for new and existing IVD and RUO products
  • Work with program managers and scientists in the development and validation of new processes and process changes
  • Interact daily with internal regulatory and quality teams.
  • Deliver verbal and written reports to internal and external groups.
  • Train other staff as needed in the performance of existing and new procedures

Supervisory/Management Authority

  • No supervisory/management authority.

 

Education and/or Experience

  • Experience with the application of Quality System Regulations (QSR / cGMP)
  • Experience generating standard operating procedures for QC testing
  • Direct experience with quality control testing and manufacture of in vitro diagnostic devices employing real-time polymerase chain reaction (PCR) technology
  • A minimum of a Bachelor’s degree in a biological science or medical technology
  • Direct experience in the operation of instrumentation and equipment related to molecular diagnostic testing (e.g. real-time PCR instruments, automated extraction systems, capillary electrophoresis sequencers) and analysis of data generated from these instruments.
  • Minimum of 1 years experience in quality control operations involving medical devices/IVDs/biological products; minimum of 1 years in a supervisory capacity
  • Excellent written and oral communication skills, advanced organizational skills
  • Selected candidates will be required to acquire and maintain a CDC security clearance

Knowledge, Skills and Abilities

  • Must have appropriate knowledge of regulatory practices and other guidance documents
  • Demonstrated interpersonal and management skills with ability to work collaboratively with other scientists and laboratorians
  • Quality assurance system auditing experience in a government laboratory facility
  • Certified in a professional quality organization (i.e. Registered Quality Assurance Professional in the Good Laboratory Practices, Good Manufacturing Practices, ISO or other applicable areas.) Certified Quality Auditor (CQA) for example
  • Strong background in the FDA regulatory environment for medical devices or pharmaceuticals or CLIA laboratory environment
  • Prior experience working in a CLIA, GLP or cGMP environment

Work Environment

  • This position is performed in a climate controlled office environment

 

With $400 million in annual revenue, 20% growth per year, approximately 950+ active contracts serving 60+ government agencies in 25 countries, 47 states, 2 territories and 2000+ employees, Cherokee Nation Businesses’ (CNB) group of Federal Contracting Section 8(a) companies is well positioned to deliver expertise needed to solve complex technical issues. Federal Solutions provides an array of services for 12 of the 15 cabinet-level departments and agencies – from applications and data services to cybersecurity and national defense.

Why consider Cherokee Nation and our Federal Solutions business? Here are some great resources highlighting what we do and compelling reasons for joining our team!

http://cherokeenationbusinesses.com/Pages/home.aspx

http://cherokeenationbusinesses.com/careers/Pages/home.aspx

http://cherokeenationbusinesses.com/federalSolutions/Pages/overview.aspx

Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility requirements for access to classified information.

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, gender identity and sexual orientation. If you’d like more information about your EEO rights as an applicant under the law, please copy and paste the links to the following two sites: EEO Statement | EEO Poster

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may email “CNB.Compliance@cn-bus.com” for assistance. This email address is for accommodation requests only and cannot be used to inquire about the application process or status.

For Pay Transparency Non Discrimination provision, please copy and paste the following link: Pay Transparency Nondiscrimination Provision

We maintain an Affirmative Action Plan for the purpose of proactively seeking employment and advancement for qualified protected veterans and individuals with disabilities. Upon request, we will schedule time to make our Affirmative Action Plan accessible. If you are interested, please submit a written request with the email subject line: 2018 Request to View Affirmative Action Plan to the Compliance Administrator at “CNB.Compliance@cn-bus.com” This email box is not for resumes or follow up on job applications.