PRIMARY PURPOSE:
Reviews manufacturing and post processing records for acceptability. Monitors environmental conditions for acceptability.
Schedule for this role is Mon - Fri: 6a - 2:30p
ESSENTIAL FUNCTIONS
- Audits manufacturing records and approves tissue grafts for release to distribution.
- Monitors processes and evaluates the need for preventive action.
- Initiates deviation documentation when appropriate and ensures appropriate notifications and tissue quarantine is completed.
- 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.
- Performs environmental testing and follow-up.
- Recognizes and solves problems; assists the department with implementation of solutions.
- Monitors temperature-controlled equipment and investigates deviations.
- Assists in validation initiatives as needed.
- Actively participates in the implementation of corrective and preventive actions and performs effectiveness checks as needed.
- Tracks errors, identifies trends and assists in documents error investigations.
- 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.