Quality Assurance Coordinator

Requisition Id14098

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 quality requirements and achieve consistency.
• Providing quality planning, reviews, and assistance on various tasks, project, procurements, and work processes. Provide quality assessments of work in progress, including document reviews against specifications.
• Participating in continuous improvement initiatives in support of quality and performance management. Assist in the implementation of quality tools and methods such as:
  • System and process analysis and improvement.
  • Identification and analysis of critical performance metrics.
  • Inspection planning.
  • Nonconformance processing.
  • Root cause analysis.
  • Critique analysis.
  • Commitment management.
  • Performance assessment.
• Monitoring performance and identify issues and concerns to management for review and identify appropriate actions.
• Escalating unresolved issues and concerns through the management chain as needed for resolution.
• Conducting or assisting in investigations, as requested, verifying corrective action planning and closure, and participating in resolution of quality problems, including occurrence reports, non-conformances, and Price-Anderson Amendments Act (PAAA) non-compliances.
• Applying a graded approach in the development of project plans, checklists, procedures, and guidance for organizations supported that will assure the efficient and effective deployment of management systems and related performance management.
• Building and developing relationships with peers and others to exchange feedback and lessons learned on issues and concerns. Operate and communicate effectively and efficiently with all necessary levels of management on quality issues.
• Assisting with the review of audit and assessment results, identifying the severity of findings or the risk associated with the findings to ensure the appropriate level of action is taken to eliminate the nonconformance and providing organizational support to respond to internal and external assessments with evaluation and closure of concerns and commitments.
• Serve as the technical or quality expert by responding to targeted questions from management and provide support to customers. Assist with obtaining and managing feedback.
• Deliver ORNL's mission by aligning behaviors, priorities, and interactions with our core values of Impact, Integrity, Teamwork, Safety, and Service. Promote diversity, equity, inclusion, and accessibility by fostering a respectful workplace- in how we treat one another, work together, and measure success.

Accountabilities:

The Quality Assurance Coordinator is accountable:

• To the Production Medical Isotope Program Manager for creating and reporting KPIs for Documentation.
• To the REDC Laboratory Chemical Operations Group Leader for ensuring controlled documents are readily available and the most current version for Production personnel; for providing oversight and feedback on GDP compliance to the Production team; and for issuing and reviewing batch records and associated production documents.
• To the Quality Representative Lead for performance of assigned tasks and work scheduling.

Authorities:

The Quality Assurance Coordinator is authorized to coordinate and recommend appropriate actions/responses to ensure the Quality System is implemented within the project.

Basic Qualifications:

• BS in technical, business, or related field, with a minimum of 8 years relevant experience or an equivalent combination of education and applicable experience.
• A minimum of 2 years of work experience in an FDA-regulated environment.
• A minimum of 2 years of experience managing Documentation Systems in a GDP environment.
• Excellent knowledge of Good Manufacturing Practices; 21CFR Parts 11, 210, 211; and ICH Q7.
• Strong analytical and problem identification/resolution skills are required; Quality focused and detail-oriented.
• Excellent communication skills. Ability to work and communicate (written and oral) effectively with diverse teams of engineers, scientists, and technicians.
• Self-motivated and able to work with minimal oversight.
• Proficiency in Microsoft Office products (Word, Powerpoint, Excel, Teams).

Preferred Qualifications:

• Advanced degree in a technical field.
• Experience in a regulated pharmaceutical industry (e.g. FDA, EPA, TGA, etc.).
• Strong interpersonal and training skills.
• Experience in development and execution of Controlled Documentation systems.
• Experience using DOE/ORNL documentation systems (e.g. SBMS, EDRM, etc.).
• Experience with change management.
• Proven ability to manage multiple priorities in a fast-paced environment.
• Experience with DOE safety, security, and regulatory requirements.

This position is a full-time staff position.

Visa sponsorship is not available for this position.

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About the Isotope Science and Engineering Directorate (ISED):
Established in 2020, theIsotope Science andEngineering Directorate is strengthening Oak Ridge National Laboratory's leadership in isotope production and enrichment technology innovation. ISED is guiding the Lab's pursuit of the fundamental science and technology that broadens the application of isotopes for energy, environmental, medical, and national security purposes. These efforts are made possible through the High Flux Isotope Reactor, the Radiochemical Engineering Development Center, ORNL's other nuclear facilities, and an assemblage of world-leading scientists and engineers. Please visit https://www.ornl.gov/directorate/isotopes for more information about ISED.

About ORNL:

As a U.S. Department of Energy (DOE) Office of Science national laboratory, ORNL has an extraordinary 80-year history of solving the nation's biggest problems. We have a dedicated and creative staff of over 6,000 people! Our vision for diversity, equity, inclusion, and accessibility (DEIA) is to cultivate an environment and practices that foster diversity in ideas and in the people across the organization, as well as to ensure ORNL is recognized as a workplace of choice. These elements are critical for enabling the execution of ORNL's broader mission to accelerate scientific discoveries and their translation into energy, environment, and security solutions for the nation.

ORNL offers competitive pay and benefits programs to attract and retain individuals who demonstrate exceptional work behaviors. The laboratory provides a range of employee benefits, including medical and retirement plans and flexible work hours, to support the well-being of you and your family. Employee amenities such as on-site fitness, banking, and cafeteria facilities are also available for added convenience.

Other benefits include the following: Prescription Drug Plan, Dental Plan, Vision Plan, 401(k) Retirement Plan, Contributory Pension Plan, Life Insurance, Disability Benefits, Generous Vacation and Holidays, Parental Leave, Legal Insurance with Identity Theft Protection, Employee Assistance Plan, Flexible Spending Accounts, Health Savings Accounts, Wellness Programs, Educational Assistance, Relocation Assistance, and Employee Discounts.

If you have difficulty using the online application system or need an accommodation to apply due to a disability, please email: ORNLRecruiting@ornl.gov

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This position will remain open for a minimum of 5 days after which it will close when a qualified candidate is identified and/or hired.

We accept Word (.doc, .docx), Adobe (unsecured .pdf), Rich Text Format (.rtf), and HTML (.htm, .html) up to 5MB in size. Resumes from third party vendors will not be accepted; these resumes will be deleted and the candidates submitted will not be considered for employment.

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