Quality Control Specialist II
Executed in-process and documentation review for all testing performed in the laboratory, accuracy and integrity of test results and transfer of test results to the customer. Monitored and evaluated the ongoing and overall quality of the total testing process to ensure the safety, quality, identity, purity and potency of the blood supply was maintained. Assisted with the facilitation of operations and education.
- Selected by supervisor to design and implement a Kaizen 5S event that reduced office waste by 80% and maximized productivity within the Quality Control Department.
- Promoted to a level II position within 4 years due to exceeded performance, stance and drive of company goals.
- Instructed quality control staff on processes and procedures and assessed yearly competency evaluations for performance.
- Reviewed all laboratory batch records and test results at 100% for completeness and accuracy with no erroneous release of product as a result of a QC review failure.
- Achieved internal and external customer expectations by fulfilling turnaround times for testing at a goal of 97%.
- Identified deviations and ensured proper corrective actions by initiating Problem Investigation Forms and utilizing CAPA software in compliance with policies, procedures and regulations.
- Handled trend analysis of external run controls and kit lot data using a propriety data management system.
- Participated in implementation meetings with management for new process changes within the laboratory to make the workflow more efficient.
- Collaborated with education and testing support to verify user documents for quality control.
- Engaged in scheduled continuing education classes to remain current with GMP and agency authorities.