Quality Assurance Specialist

Job Description

Job Description

Quality Assurance & GMP Compliance

• Support compliance with Good Manufacturing Practices (GMP), internal procedures, and regulatory requirements.
• Collaborate with department management to investigate quality issues and develop strategies to prevent recurring deviations.
• Report potential quality or compliance concerns to Quality Management in a timely manner.
• Create, update, and review Standard Operating Procedures (SOPs) and other controlled documents in compliance with GMP requirements.

Investigations & Complaint Management

• Lead, initiate, track, and trend investigations related to customer product complaints.
• Review reported complaints for accuracy and completeness prior to triaging.
• Assist subject matter experts with root cause analysis and corrective action activities.
• Utilize technical writing practices to ensure investigations are clear, concise, and well-documented.
• Provide customer support related to product complaints through phone and email communication.

Quality Systems & Data Management

• Compile, maintain, and analyze quality performance metrics and trend data.
• Support MasterControl system administration activities, including troubleshooting and process improvements.
• Maintain accurate and compliant quality records and documentation.

Audits & Regulatory Support

• Perform internal audits to assess compliance with regulatory, quality, and procedural requirements.
• Participate in external audits conducted by regulatory agencies and provide documentation and audit support as needed.
• Support continuous improvement initiatives resulting from audit findings and quality trends.

Calibration & Equipment Oversight

• Ensure equipment calibrations are completed according to defined schedules and GMP requirements.
• Review and approve calibration certificates and maintenance records to verify equipment remains within acceptable operating parameters.
• Coordinate follow-up activities related to equipment calibration or maintenance issues.