Quality Assurance Specialist

PCCA; Houston (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

PCCA in Houston, TX seeks a Quality Assurance & GMP Compliance professional to uphold GMP standards, internal procedures, and regulatory requirements. You will work with management to address quality issues and prevent deviations, while maintaining SOPs and controlled documents.

You will lead investigations, manage complaints, analyze quality data, support MasterControl, and assist with audits. Calibration oversight and documentation completion are also involved.

Responsibilities

• Support compliance with 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 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.

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.