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Job Title: Quality Assurance Specialist (Temporary)
Job Number: 1911-04425-QAS-001
Organization: IHRC, Inc.
Posted: 11/26/2019
Type: Full-Time
Classification:
Industry:
Number of Openings: 1
Location: Atlanta,  GA    USA
Compensation: Commensurate with qualifications and experience
Position Description:

JOB TITLE:   Quality Assurance Specialist (Temporary)

POSITION NUMBER:  1911-04425-QAS-001

POSITION LOCATION:  Atlanta, GA, USA

ANTICIPATED START DATE:  Two weeks after candidate identification

TRAVEL:  As required to fulfill the responsibilities of the position

IHRC, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients.  The successful candidate will be assigned to the Laboratory Preparedness and Response Branch (LPRB), Division of Preparedness and Emerging Infections (DPEI), National Center for Emerging and Zoonotic and Infectious Diseases (NCEZID), at the CDC, 1600 Clifton Road, Atlanta, GA, and will provide quality assurance support for the development and deployment of quality assays and products to LRN member laboratories, the continuous monitoring and improvement of the branch quality management system, and the enhancement of existing and next generation assay development research activities, and the public health capacity of the LPRB. This is a temporary assignment that will end April 30, 2020.

The mission of the LPRB is to develop and validate new technologies for rapid identification of unknown samples, to provide rapid assays to the Laboratory Response Network (LRN), and to support the LRN with technical expertise in all assays deployed to the LRN through:

  • Developing, evaluating, and validating rapid methods for identification of bacterial agents using advanced technologies
  • Developing extraction methods for various sample types to facilitate rapid identification of bacterial agents in environmental and clinical samples
  • Providing training and consultation on technical issues associated with LRN protocols
  • Overseeing the development and deployment of new methods and technologies by the LRN technical review committee (TRC)
  • Establishing procedures for Performance, Production, Quality Assurance (QA) and Quality Control (QC) for LRN reagents
  • Working with federal agencies such as FBI, DHS, DoD, and EPA to coordinate response procedures

Within LPRB is the Product Development Team, which develops assays and works closely with CDC subject matter experts (SMEs) to support the LRN with research and development of new methods. The Product Development Team provides real-time PCR testing for bacterial and viral agents, and collaborates with CDC SMEs, as well as LRN labs in developing, evaluating, and validating novel rapid methods for pathogen identification. The team facilitates the review of all assay data and documentation through the Technical Review Committee (TRC), a requirement for All LRN Assays.

SCOPE OF WORK

The Quality Assurance Specialist (Temporary) will support the development of quality diagnostic assays that utilize technology including but not limited to real-time PCR and ELISA, and their deployment to LRN member laboratories.

MAJOR DUTIES AND RESPONSIBILITIES

  • Provide administrative oversight of feedback, complaints, non-conforming events and Corrective Action Preventive Action (CAPA) and/or document control systems to ensure compliance to established procedures
  • Collaborate with LPRB Quality Assurance Team Lead to ensure staff training compliance within the branch
  • Collaborate with LPRB Quality Assurance Team Lead to ensure the Bioterrorism Rapid Response and Advanced Technology Laboratory (BRRATL) is in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations
  • Generate statistical tracking and trending reports on a regular basis to monitor compliance to established quality system requirements

Qualifications:

MINIMUM QUALIFICATIONS

Education and Experience:

  • Bachelor’s Degree with 1-3 years of experience in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, or other field related to the position

Required:

  • Experience reviewing written quality or inspection procedures for adequacy and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans.
  • Experience analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system
  • Experience identifying inadequacies and requesting corrective action
  • Experience reviewing change requests (CR) for completeness
  • Experience working within a multidisciplinary scientific environment
  • Experience ensuring compliance with all contract and task order requirements and quality standards
  • Knowledge of biosafety requirements for research being performed
  • Strong interpersonal skills and extensive experience interacting with internal and external partners
  • Experience working with Visio and Microsoft Office; including, Word, Access, Excel, and PowerPoint
  • Immunizations may be required

Desirable:

  • Experience working with Pilgrim SmartSolve eQMS software
  • Knowledge of real-time PCR, ELISA, and other technologies
  • Skills and experience writing project reports, research protocols and manuscripts
  • Ability to meet or exceed project deliverables and timelines 
  • Experience using statistical software such as SAS, or SPSS to analyze assay data
  • Experience developing real- time PCR, ELISA, or next-generation sequencing in vitro diagnostic assays
  • Familiarity with records management processes
  • Familiarity with CDC Records keeping and archiving systems, such as CDC Vault

Language Skills:

  • The candidate must possess excellent oral and written communication skills in English    

REQUIREMENT: Must be United States citizen or permanent resident or have authorization for employment in the United States

SALARY:  Commensurate with qualifications and experience

To apply for this position:

  • If you are viewing this position on the IHRC Career Center, please click on the "Apply Now" button.  
  • If you are viewing this position on a site other than the IHRC Career Center, you may use the “click to apply” link, or you may apply by visiting our Career Center and searching for the position number listed at the top of this position description.  
  • To view all of our open positions, and to apply to those positions in which you may be interested, please visit our Career Center, which can also be reached by visiting www.ihrc.com/Careers and clicking on the “View Opportunities” link.

IHRC, INC. IS AN EQUAL OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.  It is the policy of IHRC, Inc. to provide equal employment opportunities without regard to race, color, religion, citizenship, age, sex, sexual orientation, gender identity, national origin, ancestry, genetic information, veteran or disability status, or any other characteristic protected by applicable federal, state or local law, and to take affirmative action in accordance with applicable laws and Executive Orders.

 

Organization Description:

IHRC, Inc. is an international consulting and professional services corporation, and a minority woman-owned small business located in Atlanta, Georgia, USA. We assist our clients in accomplishing their missions and objectives in a timely and cost-effective manner, and we strive exceed our clients’ expectations.

Closing Date: 2/26/2020
Desired Starting Date:
Contact Name: HUMAN RESOURCES,  Quality Assurance Specialist (Temporary)
Contact Location: 2 Ravinia Dr. Suite 1200

Atlanta   GA  30346
United States
Contact Location: 2 Ravinia Dr. Suite 1200
 
  Atlanta   GA  30346
  United States
Contact Phone:  
Contact Fax:
Contact Email: resume@ihrc.com
Web Address: https://www.ihrc.com
How to Apply:

Click here

Additional Information:

Web Site Delete Date: 12/26/2019