Quality Assurance Specialist

Ihrcorporated • Atlanta, GA

6d

About The Position

IHRC Inc. seeks a dedicated and experienced Quality Assurance Specialist to support our clients at Centers for Disease Control and Prevention (CDC)/Coronavirus and Other Respiratory Viruses Division (CORVD). CORVD’s mission is to provide the health of people by preventing illness, disability and death from respiratory viruses through public health science and practice in the United States and globally. This position is needed for accomplishing CORVD’s mission. The specialist will provide consultation, training, and oversight to ensure compliance with federal regulations and CDC policies. Provide consultation to CDC staff in the training of quality managers, laboratory staff, senior scientists, and laboratory support staff. Translate laboratory quality requirements from the Code of Federal Regulations, international standards, and national standards into functional requirements for laboratories. Utilize strategic planning and project management to develop Quality Management System (QMS) implementation strategies within diverse laboratory environments. Ensure quality management practices are incorporated across all laboratory operations including diagnostic testing, surveillance testing, research, and product development. Assist laboratories in preparing for internal and external audits. Perform GAP analyses and generate/review Nonconformance Events (NCEs) and assist laboratories in generating corrective action plans. Draft risk assessments and ensure appropriate clearance. Communicate agency quality and safety initiatives to branch members.

Requirements

• Bachelor’s degree (BA/BS) with 0–3+ years’ experience
• Must be United States citizen or permanent resident or have authorization for employment in the United States
• The candidate must possess excellent oral and written communication skills in English

Nice To Haves

• Work experience in the scientific field, including laboratory safety, quality control, quality assurance, or related field (preferably in a public health setting)
• Knowledge of and experience working with laboratory safety, quality control and quality assurance
• Knowledge of and experience working with clinical data and working in a clinical laboratory
• Familiarity with word-processing, presentation, and email software
• Ability to identify gaps in existing resources
• Ability to be flexible
• Interpersonal communication: telephone, email, and business etiquette
• Strong proofreading skill and attention to detail
• Strong organizational skills

Responsibilities

• Provide consultation, training, and oversight to ensure compliance with federal regulations and CDC policies.
• Provide consultation to CDC staff in the training of quality managers, laboratory staff, senior scientists, and laboratory support staff.
• Translate laboratory quality requirements from the Code of Federal Regulations, international standards, and national standards into functional requirements for laboratories.
• Utilize strategic planning and project management to develop Quality Management System (QMS) implementation strategies within diverse laboratory environments.
• Ensure quality management practices are incorporated across all laboratory operations including diagnostic testing, surveillance testing, research, and product development.
• Assist laboratories in preparing for internal and external audits.
• Perform GAP analyses and generate/review Nonconformance Events (NCEs) and assist laboratories in generating corrective action plans.
• Draft risk assessments and ensure appropriate clearance.
• Communicate agency quality and safety initiatives to branch members.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees