Quality Control Specialist I

PRIMARY PURPOSE: Reviews manufacturing and post processing records for acceptability. Monitors environmental conditions for acceptability. ESSENTIAL FUNCTIONS 1. Audits manufacturing records and approves tissue grafts for release to distribution. 2. Monitors processes and evaluates the need for preventive action. 3. Initiates deviation documentation when appropriate and ensures appropriate notifications and tissue quarantine is completed. 4. Performs inspection and review of tissue grafts/packaging, ensuring that all grafts released for processing, packaging, labeling and/or distribution meet all applicable regulations, standards, and customer specifications. Ensures proper disposition of all products. 5. Performs environmental testing and follow-up. 6. Recognizes and solves problems; assists the department with implementation of solutions. 7. Monitors temperature-controlled equipment and investigates deviations. 8. Assists in validation initiatives as needed. 9. Actively participates in the implementation of corrective and preventive actions and performs effectiveness checks as needed. 10. Tracks errors, identifies trends and assists in documents error investigations. 11. Performs other duties as assigned. MINIMUM REQUIREMENTS EDUCATION and/or EXPERIENCE Quality Control Specialist I • High School Diploma or equivalent. Quality Control Specialist II • Satisfactory performance as a Quality Control Specialist I for a minimum of 18 months. • Successful completion of 75% Category I training modules as defined on the position master list. Quality Control Specialist III • Satisfactory performance as a Quality Control Specialist II for a minimum of 18 months. • Successful completion of 100% Category I and 75% of Category II training modules. • CTBS certification and/or Bachelor’s degree. WORK ENVIRONMENT and PHYSICAL ACTIVITIES • Must be able to meet the required physical demands with or without reasonable accommodation. • Periodic travel between the Dayton and Kettering Ohio facilities may be required. DESIRED QUALIFICATIONS • Bachelor’s degree from an accredited college preferred. • Minimum of three years’ experience in quality control, quality assurance, clinical laboratory, tissue banking, or pharmaceutical/other manufacturing environment. • Certified Tissue Bank Specialist (CTBS) certification. • Technical and professional experience in analyzing process opportunities and developing and implementing strategies for improvement. • Knowledge of applicable regulatory requirements from AABB, AATB, FDA, OSHA & ISO. • Experience in auditing, quality control, quality assurance, clinical laboratory, blood/tissue banking, or pharmaceutical/other manufacturing environment. • Sound knowledge and understanding of GMP & GTP requirements and industry standards. • Proficiency in Microsoft Word and Excel programs. • Demonstrated ability to: ◦ Influence and persuade others through verbal & written communication skills. ◦ Stay organized and maintain records. ◦ Work in a fast-paced environment and juggle competing tasks & demands.