1. Daily supervision of Quality Supervisor (QS) and back-up QS for coordinating work within an
IBR Plasma Center.

2. Monitor all established quality activities in place. Ensure that they are effective,
feasible and continue to produce desired results; recommend corporate wide improvements.

3. Assure compliance with SOPs and that SOP revisions are implemented correctly.  Suggest SOP
changes to make the systems more efficient and effective.

4. Interact with center Quality Supervisor and center management to develop corrective actions
for inspectional findings and assure they are implemented and effective. 

5. Assure that required proficiency testing is performed and reported accurately.

6. Assure deviations/incidents investigating and reporting are handled appropriately. 

 � Evaluate adequacy of corrective actions and completeness of reports, assist in root cause
analysis. 

 � Investigate and propose additional corrective actions as required.

 � Monitor compliance of corrective actions where indicated through various systems in place.

7. Respond to QA Tracking and QA Trending errors, external audit findings, and internal audit
findings; recommend corrective actions to operations for implementation; monitor corrective
actions for effectiveness.

8. Train other designated staff in performing the functions of the QS position.

9. Through internal audits, daily observations and other means, identify issues that may lead
to non-conformance and work with corporate staff to resolve.

10. Work effectively with the Center Manager and corporate staff to ensure daily operations are
in full compliance with all requirements at all times.

11. Mentor all staff in achieving a more in depth understanding and application of cGMP