What are the responsibilities and job description for the Quality Assurance Specialist position at Steri-Tek?
Here's what Steri-Tek offers team members:
- $26.00 - $30.00 per hour
- Medical, dental, vision, life insurance, 401(k) match, PTO and more.
- Growth potential - opportunities for career development and networking!
- Exposure to and collaborations with experts in the biotech, medical device, and pharmaceutical industries.
Here's what you will be doing as part of our team:
- Complete any task assigned by the Quality Manager
- Maintain clean and organized work area
- Once all primary tasks are complete, assist other employees and departments as assigned by the Quality Manager or CEO
- Complete continuing education requirements described during performance review
- Complete and ensure proper execution of the Steri-Tek Quality Manual
- Ensure that Steri-Tek follows ISO requirements and other regulatory standards including ISO 11137:2006 and AAMI TIR 29:2002.
- Review Job Records at specified intervals for accuracy and completeness (QA1, QA2, QA Approval, QA Final).
- Ensure incoming products have been received and prepared for processing as described in Receiving & Pre-Processing Product for Irradiation Work Instruction (WI).
- Contact customers as required to resolve any discrepancies with incoming product.
- Review Run Records for accuracy and completeness and confirm processed product has been completed per specifications as described in WI - Job Record Review and Product Release.
- Ensure all SOP’s, forms, labels and other quality related documents are current and accurate. Initiate or review changes to controlled documents following document control SOP’s and WI’s.
- Follow WI - Document Control when processing requests for the creation of new documents or changes to current documents.
- Ensure all submitted Document Change Orders are complete and accurate.
- Acquire approval from specific departments according to the chart on page 3 of WI - Document Control.
- Acquire customer approval when needed.
- Complete new documentation implementation and distribution.
- Maintain all records associated with Document Control – both electronic and hard copy.
- Assist the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs.
- Send notifications or schedule appropriate activities for QMS programs.
- Perform investigations, execute corrections.
- Schedule and/or perform calibrations for equipment.
- Schedule and/or perform preventive maintenance for equipment.
- Manage due dates and implementation dates for QMS programs.
- Collect and/or create any documentation required for QMS programs.
Salary : $26 - $30
