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Quality Assurance Specialist II, Atlanta, GA, US ID#16159

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    

We are seeking a Quality Assurance Specialist to support auditing, reporting, implementation, oversight, maintenance and continuous improvement of Quality System processes for laboratories performing diagnostic testing of patient specimens, surveillance, research activities, IVD and RUO manufacturing, etc. The Quality Assurance Specialist will assist the QA team with the continuous improvement of a Laboratory Quality System that complies with Clinical Laboratory Improvements Amendment (CLIA), ISO 9001, Good Manufacturing Practices (GMP) per 21 CFR 820, and Good Laboratory Practices (GLP) per 21 CFR Part 58 as appropriate.

The US Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC)/National Center for Immunization and Respiratory Diseases (NCIRD)/ Influenza Division (ID) requires support in the areas of laboratory surveillance, monitoring of novel and antiviral-resistant influenza viruses, and establishing more effective antiviral drugs and treatment.

Essential Duties and Responsibilities

  • The contractor will apply specialized skills to conduct work including one or multiple of the following responsibilities:

  • Assist with document control and training related to Quality Systems
  • Prepare, review, and route procedures for approval
  • Prepare new staff training plans as well as ongoing quality training, as needed
  • Assist with entry and maintenance of the training database
  • Monitor competency assessment completion by each team
  • Assist with the maintenance of equipment records
  • Review of batch records and design history records, as needed
  • Assist the Quality Manager with the continuous improvement of a Laboratory Quality System
  • Conduct internal audits of laboratories, laboratory data, methods, processes, and computer systems
  • Assist with nonconformance documentation and evaluation
  • Assist with root cause analysis and preparation of corrective actions concerning audit findings
  • Communicate progress orally and in writing with technical monitor and others

Supervisory/Management Authority

  • No supervisory/management authority.

Education and/or Experience

Mandatory

  • MS or BS Degree in biology, microbiology, virology, biochemisty, or other life science
  • Have at least 1-year quality assurance experience in microbiology/diagnostic CLIA and or ISO certified laboratories, medical device manufacturing, or pharmaceutical industry or similar
  • 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

Highly Desired

  • Experience with the application of Quality System Regulations (QSR/cGMP)
  • Experience generating standard operating procedures for QC testing

Knowledge, Skills and Abilities

  • Must have appropriate knowledge of regulatory practices and other guidance documents
  • 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.