Quality Assurance Specialist

1.

Quality System Documentation - Helps in the development and updating of quality system documentation and records. Supports records and document control, and production and process control.  Aids the Quality Supervisor in the transition to new standards as they develop.                                                                             (Essential)                    

20%

2.

Change Management - Administrates the change management system.  Ensures validation of changes and associated risk analysis are completed and documented.                 (Essential)

20%

3.

Quality System Auditing - Leads scheduled risk based internal audits.  Updates the Audit Log, documents findings and works with departments to provide effective corrective action.  Participates in external audits.                      (Essential).

20%

4.

Corrective and Preventive Action (CAPA) - Takes an active role in facilitating the Corrective Action process. Takes initiative in problem-solving for continuous quality improvement relative to raw materials, product testing and product performance. Communicates continuous improvement suggestions to management regarding quality issues and concerns of customers.  Submits quarterly CAPS report to management.                                                                                            (Essential)

20%

5.

Technical Writing - Helps develop technical documentation quality procedures, work instructions, calibration procedures, quality plans and quality related forms.                            (Essential).

10%

6.

Process Control – Plans, conducts and oversees test and inspection of materials and products (ex Sampling) to ensure quality is maintained.  (Essential)                                                                                                    

10%

7.

Performs other functions or duties as assigned.          (Supplemental)

0%