Quality Assurance Position Opening in NIDC

This position has been filled.

The Oak Ridge National Laboratory (ORNL) seeks to hire a Quality Assurance Specialist. The position is in the Isotope Business Office (IBO) reporting to the IBO Manager. The QA management function is part of the National Isotope Development Center (NIDC). The NIDC QA Specialist is responsible for development, implementation, and maintenance of an integrated quality assurance system for the Department of Energy’s Isotope Program (DOE-IP).

Major Duties/Responsibilities:

The QA Specialist works directly with the DOE-IP Site Program Managers to develop, implement, and maintain a quality system to meet regulatory, operational, and customer specifications for all stable and radioisotope products produced at the multiple sites. The approved QA system shall encompass the product life-cycle beginning with specifications in the NIDC catalog and ending with a certified product at the time of delivery to the customer. The QA Specialist shall be responsible for providing advice on compliance with the applicable quality assurance regulations at the IP sites and shall participate in audits conducted by regulatory authorities and customers.

Other responsibilities include:

  • Develop a quality system for DOE-IP in compliance with ICH Q7 for facilities and equipment, manufacturing and analytical testing, facility and environmental requirements, raw materials, personnel and final product specifications.
  • Assist IP sites to evaluate, design and implement current Good Manufacturing Practices (cGMP) such as purchasing and storage of raw materials/components, qualification, stability, validations, procedures, documentation system, process controls , testing and distribution of DOE-IP radiopharmaceutical ingredients.
  • Monitor and provide direction to ensure compliance by establishing systems such as trending data, internal audits and corrective and preventative action (CAPA) for compliance to ICH Q7, ASME-NQA1 and ISO 9001:2008 as they relate to the DOE-IP.
  • Provide technical and administrative leadership on all aspects of quality control/quality assurance functions. This includes quality control labs, equipment, method qualification and validation, strategic planning, budgeting and staffing.
  • Support site operations personnel during audits by regulatory authorities and customers.
  • Develop and maintain a DOE-IP QA Plan.
  • Define content and format for catalog specifications, work authorizations, analytical data, and product certification for all DOE-IP products and services.
  • Develop guidelines for ensuring quality and quantity verification for all isotope shipments.
  • Document all customer complaints/issues and develop associated corrective actions at all sites.
  • Document and measure performance to DOE-IP metrics at all sites.
  • Manage selected product lines as requested by management.

Qualifications Required

  • A Bachelor’s Degree in science, engineering, or related field with 5 to 12 years of quality experience.
  • Must be extremely self-motivated, creative, and passionate with excellent written and oral communication skills.

This position requires the ability to obtain and maintain a DOE “Q” security clearance.

Qualifications Desired

  • Lead auditor certification.
  • Experience working in FDA-regulated and/or ICH Q7 quality assurance environment at a radiopharmaceutical facility.

ORNL is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply.

Point of Contact:
Lorrin Howard
Oak Ridge National Lab