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 must be familiar with tissue bank processes and quality system requirements. In accordance with IntegoGen, LLC (ITG) Quality Manual and Standard Operating Procedures (SOPs), the QSS will follow all applicable regulatory standards.

1. Comply with FDA, AATB, OSHA, cGTP, cGDP, cGMP and state rules and regulations at all times.

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:

· Review of processed tissue for consistency with specific tissue requirements.

· 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.

· Verification that all processing was accomplished within time limits specified in the SOP’s and within applicable technical specifications (e.g., cryopreservation temperatures, irradiation exposure limits acceptable; pressure readings acceptable).

· 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.

· 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.

4. Responsible for the preparation of technical records for review, inspection of allografts and change in status of allografts in the inventory system.

5. Responsible for maintaining and updating task lists and schedules regarding inventory flow and release.

6. Knowledgeable of computer systems and able to perform all functions as required.

7. Ensure product irradiation runs and products required to be in quarantine are verified and identify and expedite any reworks as required.

8. As a member of the quality systems department, Quality personnel are required to be able to complete a nonconformance report, corrective / preventative action report, a complaint report and a deviation report according to established SOP requirements.

9. 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.

10. Verify with the Operations Manager that the setup, shipment, tracking and receipt of all tissue that is sent for irradiation /sterilization.

11. Ensure that all products are prepared for irradiation runs by concurrently performing all Quality inspection steps in line with production; ensure all technical tests have been run correctly, and reported within specifications, and ensure that all necessary documents has been submitted for the sterilization runs.

12. Ensure that each tissue is inspected per the Final Packaging Specification (if required), packaging integrity and final label(s) prior to setting final disposition.

13. Ensure that tissue identification, determination of dimensions/specifications, and labeling steps are in compliance in order to prevent misidentification and mislabeling errors.

14. Ensure packaging is performed per the applicable SOP and that graft packaging is within the required specifications for packaging.

15. Accountable for following cGTP, CFR, SOP, labeling in-coming inspection, printing labels, stage labeling for packaging, label inventory control, reconciliation, archiving documents, and updating electronic inventory systems.

16. Works closely with Operations Personnel to prepare components for labeling and packaging of product after processing sessions have been completed.

17. Will be required to perform any other task or function within the quality systems department on an as-needed or emergency basis (e.g. evenings and weekends) 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
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility
• Office

Ability to Relocate:

• Tallahassee, FL 32308: Relocate before starting work (Required)

Work Location: In person