Description of job:
The Quality Representative (QR) works with customers and other quality professionals to develop a quality philosophy, tools and techniques, quality management systems, business/process improvements, strategic planning and performance metrics, and other quality-related initiatives to support Laboratory operations.
The QR will support the development and implementation of quality requirements supporting the ORNL Isotope Program focusing on FDA Current Good Manufacturing Practice (cGMP) and development of radioactive medical products.
Job Duties and Responsibilities:
- Developing and maintaining quality programs meeting the requirements of cGMP, including: conducting internal assessments/product reviews, managing documentation, preparing for regulatory audits/inspections and interacting with auditors and investigators.
- Developing/maintaining quality assurance plans and procedures that address the requirements of cGMP and the Laboratory quality plan as needed.
- Ensuring that certain medical isotope production activities are conducted in compliance with current Good Manufacturing Practice standards.
- Using technical and quality expertise to review and release batches of active pharmaceutical ingredients.
- Working with manufacturing and quality control personnel to provide technical expertise in the resolution of quality issues.
- Developing, managing and releasing product batch records and standard operating procedures.
- Providing technical and administrative leadership on all aspects of quality control/quality assurance functions. This includes product development, equipment, method qualification and validation, addressing customer complaints and issues, CAPA implementation, strategic planning, budgeting and staffing.
- Assisting managers with ORNL quality-related systems, tool, and processes, such as those for handling issues, documents, records, calibration, configuration control, procurement, inspections, etc.
- Maintaining awareness of ORNL expectations through participation in staff meetings and the review of institutional documents.
- Advising responsible managers of quality requirements and suggesting options for implementation and integration with environmental, health, safety, and security requirements.
- Developing a self-assessment plan and implementing the plan to assess activities to identify areas of success and opportunities for correction/improvement/prevention.
- Serving as an independent quality reviewer for reports, procedures, statements of work, procurement documents, proposals, plans, etc.
- Operating and communicating effectively and efficiently with all levels of management on quality issues.
- Establishing relationships and working effectively with both external and internal customers to meet goals and assess customer satisfaction.
- Identifying and understanding customer needs while influencing the prioritization and development of quality initiatives.
- Building and developing strong relationships with peers and others to exchange feedback on issues or concerns.
- A Bachelor’s Degree in science, engineering, or related field with 5 to 7 years of quality experience, or an equivalent combination of education and experience, is required.
- Exceptional teamwork and statistical skills, with attention to detail and precision are required.
- Experience in radiochemistry, radiopharmacy and/or nuclear medicine is highly desirable.
- Experience in implementing and maintaining compliance with the requirements of cGMP is desired.
- Experience working in an FDA-regulated environment at a radiopharmaceutical facility is desired.
- Knowledge of ICH Q7, USP, State Pharmacy Board and international drug and/or device regulations is desired.
- Understanding and experience with implementation of change control is desirable.
- Knowledge of maintaining a Drug Master File is desirable.
- Knowledge of sterile product manufacturing is desired.
- Experience with handling external audits and assessments is desired.
- Knowledge of NQA-1 standards is desired
- Experience interacting with auditors, especially the FDA and other regulatory agencies, is desired.
- Experience working cross-functionally to interpret requirements and educating others on those requirements.
- A demonstrated track record of investigation analysis and problem solving.
- Extremely self-motivated, creative, and passionate with excellent written and oral communication skills and the ability to multi-task.
- Work experience and/or training involving nationally or internationally recognized quality standards or quality-related regulations.
- Experience with integrating various requirements into a cohesive, effective, efficient approach.