Quality Assurance Associate- (Quality)

Reports to: Quality Assurance Supervisor or Manager

Responsibilities:

• Conducts Annual Drug (Product) Reviews and Device History Reviews.

• Maintains Regulatory Compliance documents and documents of external origin.
• Maintain Document Control (including Records Retention)
• Participates in internal and external audit process.
• Participates in Mock (product) recall audits.
• Maintain SOPs and Quality Forms as part of Document Control.
• Maintains records of customer-approvals documents as evidence of authenticity.
• Participate in QA Audits and draft reports of such audits.
• Effects changes to specification sheets as approved through change control requests.
• Support Change Control program and maintain evidence of product and process changes.
• Maintains SOP binders and updates such documents through approved CCs.
• Supports EWL Employee...

• Conducts Annual Drug (Product) Reviews and Device History Reviews.

• Maintains Regulatory Compliance documents and documents of external origin.
• Maintain Document Control (including Records Retention)
• Participates in internal and external audit process.
• Participates in Mock (product) recall audits.
• Maintain SOPs and Quality Forms as part of Document Control.
• Maintains records of customer-approvals documents as evidence of authenticity.
• Participate in QA Audits and draft reports of such audits.
• Effects changes to specification sheets as approved through change control requests.
• Support Change Control program and maintain evidence of product and process changes.
• Maintains SOP binders and updates such documents through approved CCs.
• Supports EWL Employee training and documentation.
• Maintains suppliers and vendors qualification program.
• Supports and...