What are the responsibilities and job description for the Quality Assurance Specialist position at Integogen?
The Quality Systems Specialist (QS) supports the Quality Management System in the functions of Quality Reviews, Quality inspections, labeling, rework, discard, and setting final disposition in the records. This position requires attention to detail and familiarity with tissue bank processes and quality system requirements. Must be able to follow written Standard Operating Procedures.
1. Comply with all applicable rules and regulations.
2. Perform quality inspections on all aspects of ITG’s work processes including but not limited to final products, review of production records for accuracy and completeness, inspection of raw materials and reagents for acceptability, and audit production work environment to stay in compliance.
3. The quality reviews and inspections also included the following:
4. Review of processed tissue for consistency with specific tissue requirements.
5. Review and compare tissue received and grafts produced from the received tissue for verification that the disposition of the tissue is traceable throughout all processes.
6. Verification that all processing was accomplished within time limits specified in the written procedures and within applicable technical specifications (e.g., cryopreservation temperatures, irradiation exposure limits acceptable; pressure readings acceptable).
7. Ensure all supplies and reagents used in each step of the tissue process is documented appropriately and that all lot/expiration dates are within applicable time frames.
8. Verify that cGDP is performed throughout all tissue processing and that required records are in accordance with the established ITG Quality Manual and SOP’s.
9. Responsible for the preparation of technical records for review, inspection of allografts and change in status of allografts in the inventory system.
10. Responsible for maintaining and updating task lists and schedules regarding inventory flow and release.
11. Capable of identifying errors, failures, nonconformance’s and deviations in various stages of production and alert the Director of Quality Systems and assist in investigating and resolving the identified concerns.
12. Ensure packaging is performed per the applicable SOP and that graft packaging is within the required specifications for packaging.
13. Works closely with Operations Personnel to prepare components for labeling and packaging of product after processing sessions have been completed.
14. Will be required to perform any other task or function within the quality systems department on an as-needed or emergency basis as assigned by the Director of Quality Systems.
Job Type: Full-time
Pay: $40,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Shift availability:
- Day Shift (Preferred)
Ability to Commute:
- Tallahassee, FL 32308 (Required)
Ability to Relocate:
- Tallahassee, FL 32308: Relocate before starting work (Required)
Work Location: In person
Salary : $40,000