What are the responsibilities and job description for the Quality Assurance Specialist position at PCCA?
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.
- 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.
- 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.
- 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.
- 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.