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Quality Assurance Control Specialist II- Atlanta, GA (ID# 14950)

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

SUMMARY

ESSENTIAL DUTIES AND RESPONSIBILITIES

Includes the following:

  • The contractor shall assist the Quality Manager with review of the quality assurance system and evaluate for continuous improvement, which includes, for example, serologic and diagnostic testing of evolving influenza viruses to ensure that developed influenza diagnostics and reagents meet quality standards and vaccines elicit protective responses to novel, current epidemic or pandemic influenza viruses.  The contractor shall report results to CDC in the monthly reports.  Some travel, both domestic and international, may be required to support certain subtasks by on site staff. To accomplish this, the contractor shall:
  • Maintain and evaluate for continuous improvement current quality assurance systems within NCIRD’s Influenza Division and recommend updates to the quality assurance program to meet requirements of ID, OID, and applicable CLIA, GLP, GMP and FDA regulatory requirements, and update the Quality Management System to meet ISO requirements.
  • Monitor and ensure compliance with Division requirements for Quality Management System (QMS) and assists with the continuous improvement of QMS systems
  • QA Support for real-time PCR kit manufacturing.
  • Monitor compliance of Quality Management System (QMS) for Zoonotic Virus Team and Virus Reference Team
  • Monitor compliance of Quality Management System (QMS) for Diagnostic Development Team
  • Route, close and publish documents under the document control process. 
  • Quality Management System (QMS) support for platform updates, new enzyme evaluations and critical reagents, etc.
  • Facilitate and coordinate appropriate QMS training for Division and Branch staff
  • Assist Division and Branches with Nonconforming Event analysis and corrective action and improvement efforts
  • Conduct periodic internal quality audits to include assessment of laboratory data and document compliance and noncompliance
  • Participate in periodic management review of the Division and or Branch QMS to evaluate its effectiveness and identify opportunities for improvement
  • Monitor required competency assessments
  • Comply with requirements to successfully complete initial and annual safety training
  • Maintain Division Water Quality Data Entry
  • Review monthly equipment logs for assigned teams
  • Maintain staff training records and database
  • Ensure the quality of all data generated by implementing the quality assurance systems and evaluating quality control inspections for compliance with established procedures and standards.  This work may also involve development of quality control materials and proficiency testing materials for evaluation of data to meet pre-established criteria.
  • Conduct manufacturing qualification testing for Influenza IVD and RUO rRT-PCR panels
  • Conduct quality control and stability testing on IVD rRT-PCR panels
  • Conduct quality control for Influenza proficiency testing panels
  • Responsible for critical and non-critical equipment in all QC labs
  • Conduct quality control on IVD rRT-PCR panel ancillary reagents
  • Manage and organize QC laboratories and equipment in accordance with CDC Quality and Safety policies and procedures.
  • Review laboratory data to ensure it meets prescribed acceptance criteria and identify trends/shifts for a given product over time.
  • Liaise with program and support training and staff development
  • Perform safety inspections and updates
  • Participate in the preparation of information for peer-reviewed journals and scientific conferences and meetings.
  • Performs other job related duties as required.

SUPERVISORY/MANAGEMENT AUTHORITY

  • This position does not have supervisory or management authority.

EDUCATION and/or EXPERIENCE

  • Bachelors or Master’s degree with at least three (3) years of laboratory experience in biology or microbiology.

KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of the principles, concepts, methods, and techniques of public health research and evaluation to analyze, evaluate and provide expert advice and consultation.
  • Knowledge of the principles, methods, applications, and state-of-the-art technology in the position's scientific area of responsibility to provide direction and guidance on critical and complex issues.
  • Ability to perform complex analytical studies and interpretation of results to coordinate the evaluation of programs and recommend improvements.
  • Ability to communicate, both orally and in writing, to make clear, convincing presentations, explain and justify recommendations, represent the agency and assigned program or project areas, provide guidance and advise program administrators and members of the community, respond to inquiries, and interact with high level officials and representatives from public and private public health organizations

WORK ENVIRONMENT

  • Work will be performed in climate controlled office environment.
  • Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility requirements for access to classified information.
  • The environment may require prolonged sitting, prolonged standing, and light lifting up to 20 lbs.

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.