Quality Assurance Coordinator

Requisition Id 14098 

 

Overview:

Oak Ridge National Laboratory (ORNL) is seeking a Quality Assurance Coordinator (QAC) for the Isotope Processing and Manufacturing Division (IPMD) at Oak Ridge National Laboratory (ORNL). This position resides in IPMD’s Operations Support Group and is matrixed to Good Manufacturing Program (GMP) Quality Unit.  IPMD is focused on processes responsible for the reliable delivery of radioisotope products to support our world class radioisotope production program. This work supports the largest radioisotope production and research portfolio within the Department of Energy (DOE) Office of Science for Isotope R&D and Production. Work is performed in gloveboxes/shielded hot cells within several unique radiological and nuclear facilities throughout the ORNL campus.

 

The QAC provides leadership in the development and deployment of quality systems, tools, and methods to facilitate accomplishing organizational and project goals.  Specifically, this QAC role will support IPMD’s Production Medical Isotope Program and provide oversight for and ownership of the GMP Documentation System. This position reports to IPMD’s Quality Assurance Lead and has accountability to the Production Medical Isotope Program Manager for the Good Manufacturing Practices (GMP) Documentation System.

 

Major Duties/Responsibilities:

This QAC’s primary focus will provide oversight for and ownership of the Current Good Manufacturing Practice (CGMP) Documentation System. Specific responsibilities include:

 

1. Current Good Manufacturing Practices (CGMP)

• Ensure compliance with 21CFR Parts 11, 210, & 211.
  • Maintains list of 21 CFR Part 11 compliant systems used by CGMP processes.
  • Performs risk assessment of all computerized systems used by CGMP processes.
• Ensure compliance with ICH Q7.
• Execute and/or oversee execution of approved policy, plans, processes, and procedures.
• Participate in internal, customer, or supplier assessments.
• Identify and recording critiques as applicable.
• Issue controlled documents for use in production.
• Perform other assigned duties, as applicable.

 

1. Document Management

• Manages cGMP document control system as document control coordinator.
• Work with EDRM system for document and records management for the CGMP cabinet.
• Advises and checks on compliance to written procedures.
• Issues a unique number for new documents.
• Reviews draft documents for required content elements, in accordance with regulatory requirements.
• Adjusts the format of draft document for consistency.
• Controls and maintains electronic and controlled copies of approved documents.
• Runs queries as requested for a list of staff that have signed as performing employees on documents.
• Ensures quality review and approval of all documents.
• Reviews final records and uploads them to Enterprise Document and Records Management (EDRM) system.
• Aids in creating/revising policy, plans, procedures and batch records, etc.
• Aids team in proofreading, merging and formatting documents.
• Serves as final reviewer for GMP documents to ensure Good Documentation Practices (GDP) requirements are met.

 

The Quality Assurance Coordinator (QAC) additional duties and responsibilities may include:

• Facilitating the integration of quality principles and methodologies (described within the Quality Assurance Program) into work planning and control processes to address contractual qua