Quality Assurance Specialist

Duties

As a Quality Assurance Specialist you will:

• Serve as a senior consultant for agency-wide laboratory quality management system programs, policies, processes, procedures, training curricula development and implementation and competency assessment for CDC Centers, Institutes and Offices (CIOs).
• Utilize a broad understanding of quality management principles to create and maintain a comprehensive quality and safety training curricula that address the full spectrum of laboratory activities, regulated and unregulated across the organization.
• Operationalize training and implement Laboratory Quality Management Systems (LQMS) and Safety and Health Management Systems (SHMS) for a wide variety of laboratories across the organization.
• Develop and coordinate standard operating procedures to document management of quality throughout the life-cycle of laboratory processes.
• Provide highly technical expertise, training and competency development in conducting complex review of laws, policies, regulations, international and national quality standards and practices associated with quality management of CDC laboratories.
• Collaborate with laboratories to develop competencies in the identification of root causes of errors and effective methods of eliminating or reducing the risk of errors.
• Provide training to quality managers, laboratory staff, senior scientists and laboratory support staff.
• Develop and coordinate a comprehensive QMS and safety training program.
• Conduct group and individual training sessions on the application of optimized laboratory processes to demonstrate regulatory compliance.

Qualifications

Applicants must have at least one year of specialized experience at or equivalent to the GS-13 grade level in the Federal service as defined in the next paragraph.

Specialized experience is experience which is directly related to the position which has equipped the applicant with the particular knowledge, skills and abilities (KSAs) to successfully perform the duties of the position to include planning, implementing and maintaining quality management systems; ensuring laboratory quality management standard operating procedures and protocols are in place; maintaining and meeting regulatory requirements and conducting internal and external quality audits.

Must be a credentialed or certified Quality Manager or actively enrolled and seeking certification by one of the following: Society for Quality Assurance or Regulatory Affairs Professional Society or American Society for Quality.

Education

Conditions of Employment:

1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.

3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.