Quality Assurance Specialist

PCCA • Full-time • Houston, TX, US • 2w ago

Collaborate with department management on investigations and develop strategies to prevent future quality deviations.
Lead, initiate, track, and trend investigations related to customer product complaints.
Verify the accuracy of reported complaints and make corrections before triaging customer product complaints.
Provide customer support and resolve inquiries related to product complaints via phone or email.
Assist subject matter experts in conducting root cause analysis.
Utilize technical writing strategies to ensure investigative reports are clear, concise, and complete.
Report potential quality issues that may impact product quality or regulatory compliance to Quality Management.
Compile and maintain quality performance metrics, analyzing trends for continuous improvement.
Create, update, and review Standard Operating Procedures (SOPs) in compliance with GMP regulations.
Assist MasterControl Sysadmins with troubleshooting issues and process improvements.
Conduct internal audits to assess compliance with regulatory and quality requirements.
Support external audits conducted by regulatory agencies, providing necessary documentation.
Ensure all equipment is calibrated on schedule and in compliance with GMP regulations.
Review and approve calibration certificates and maintenance records to verify equipment functionality.
Perform other duties as assigned.

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