Quality Assurance Associate
Grifols Biomat USA
St Joseph, MO
2021 - 2024
- Conducted quality control inspection throughout the entire production process. Including components used, equipment maintained, employees training, with final product storage and shipping.
- Tracking daily, weekly and monthly equipment calibration reports to ensure accuracy, regulatory compliance and workplace safety.
- Maintaining current knowledge of regulations and standards affecting plasma collection and donor safety.
- Following all company and FDA policies. Including cGMP, OSHA, CLIA and HIPAA.
- Performed over 250 donor charts reviews a week. Review screening questionnaires and lab results. Confirm negative viral markers (HIV, HBV,HCV) and total protein/hematocrit levels. Ensuring all documentation is accurate and up-to-date at all times.
- Investigating double purpose medication and making sure medical physician has all the necessary information and proper documentation to either approve or disqualify specific donor.
- Catching minor procedural and documentation errors. Initiating deviation reports when discovered.
- Developing and monitoring the effectiveness of implemented changes and adjusting strategies if necessary.
- Familiarity with quality control tools like donor management software, live freezer temp tracking system etc.
- Inspecting all incoming product deliveries (soft goods such as needles, Saline, AC, gauze etc) for necessary paperwork, external damage, correct quantity, expiration dates, proper storage and final sign-off.