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Job Title: Quality Management Specialist
Job Number: 1708-92032-QMS-01
Organization: IHRC, Inc.
Posted: 8/16/2017
Type: Full-Time
Classification:
Industry:
Number of Openings: 1
Location: Atlanta,  GA    USA
Compensation: Commensurate with qualifications and experience.
Position Description:

JOB TITLE: Quality Management Specialist

POSITION NUMBER: 1708-92032-QMS- 01

POSITION LOCATION: Atlanta, GA, USA

ANTICIPATED START DATE: Two weeks after candidate identification

APPLICATIONS ACCEPTED UNTIL: Position is filled

TRAVEL:  Domestic travel as required

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 a full-time employee of IHRC, Inc. and will be assigned to the Meningitis and Vaccine Preventable Diseases Branch (MVPDB) within the Division of Bacterial Diseases (DBD), at the CDC, 1600 Clifton Road, Atlanta, GA to provide support for the implementation and maintenance of the Division Quality Management Plan.

SCOPE OF WORK

The Quality Management Specialist will provide support for the implementation and maintenance of the Division Quality Management Plan and adherence to applicable guidelines and requirements.

MAJOR DUTIES AND RESPONSIBILITIES

  • Participate in the development, implementation, and maintenance of the Branch Quality Management System (QMS) and adherence to applicable guidelines and requirements established by the Clinical Laboratory Improvement Amendments (CLIA), the Food and Drug Administration (FDA), and the International Organization for Standardization (ISO).
  • Provide direct laboratory support for the implementation of quality system activities.
  • Create the schedule for, and monitor equipment calibration and preventative maintenance activities.
  • Coordinate equipment maintenance with vendors as applicable.
  • Maintain records (training, equipment, monitoring records, NCEs, etc.) in accordance with quality standards.
  • Assist laboratories with documentation and investigation of Non-Conforming Events (NCEs).
  • Prepare schedules for, and monitor competency assessments and proficiency testing.
  • Under the direction of the Branch Quality Team, work directly with laboratory staff to implement and ensure quality system requirements are met.
  • Perform document control activities as assigned by the quality team lead.
  • Assist Branch Quality Team in performing periodic internal quality audits.
  • Assist Branch Quality Team in development and collation of data for Branch quality management reviews.
  • Work with Branch Quality Team to ensure that all aspects of the Branch QMS are developed, documented, implemented, and maintained.

Qualifications:

MINIMUM QUALIFICATIONS

Education and Experience:

  • BS degree (MS degree preferred) in microbiology, biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or an equivalent science or equivalent degree from an accredited university or college of higher education.

Required:

  • Experience adhering to applicable Quality Management Plan guidelines and requirements.  (CLSI, ISO, CLIA, FDA)
  • Minimum of 3 years' experience specializing in quality management within a regulated scientific environment.
  • Ability to communicate effectively orally and in writing
  • Strong CAPA, audit, and complaint systems experience is essential.
  • Strong knowledge of established quality and reliability assurance practices, standards, and procedures, their content and applications as applied to quality systems, manufacturing processes, and production methodology.
  • Strong knowledge of Quality Control (QC) manuals, QC audit procedures, document package requirements, and overall Quality Assurance (QA) criteria specific to inspection reports, parts lists, revision levels, change orders, model numbers, classifications of defects, process test specifications, statistical sampling levels, acceptable quality levels, and others as applicable.
  • Experience using computer software packages including Microsoft Word, Excel, PowerPoint

Desirable:  

  • Minimum of 3 years of laboratory experience using molecular, immunological, and cell biology techniques.
  • Ability to build coalitions with partners involved, working with MVPD Branch members to develop strategies for effectively conveying information to partners.  
  • Ability to work independently and yet to maintain the flexibility to respond to the needs of the MVPD Branch.

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, sex, sexual orientation, gender identity, national origin, age, and veteran or disability status 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, located in Atlanta, Georgia, USA. IHRC is a minority woman-owned small business and participates in the 8(a) business development program of the U.S. Small Business Administration. 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: 11/16/2017
Desired Starting Date:
Contact Name: HUMAN RESOURCES,  Quality Management Specialist
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: 9/16/2017