Auditing, Calibration, Continuous Improvement, Corrective Action, Customer Support/Service, Data Management, Document Management, Documentation, Equipment Maintenance/Repair, External Audit, GMP (Good Manufacturing Practices), Identify Issues, Internal Audit, Performance Analysis, Performance Metrics, Process Improvement, Product Support, Quality Assurance, Quality Management, Quality Metrics, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Schedule Development, Standard Operating Procedures (SOP), Strategic Planning, Support Documentation, Systems Administration/Management, Technical Writing, Time Management, Trend Analysis
LOCATION
Houston, TX
POSTED
9 days ago
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.
About the Company
P
Professional Compounding Centers of America Inc
More than three decades ago, a physician encountered a patient who required an anti-nausea medication that was no longer commercially available. The physician challenged a Houston-area pharmacist to compound the medication, so the pharmacist consulted with his peers and procured the chemicals necessary to prepare it.
The prescription was a success, and the pharmacist realized that others in his field faced similar demands to help patients who require compounded medications. This network of pharmacists, united by a commitment to meet patient needs, was the foundation of PCCA (Professional Compounding Centers of America), which was incorporated in 1981.
Today, PCCA has become the independent compounding pharmacist's complete resource for fine chemicals, equipment, devices, flavors, ACPE-accredited training and education, pharmacy software, marketing, business and pharmacy consulting assistance. Our membership includes more than 3,900 independent community pharmacists in the United States, Canada, Australia, and other countries around the world.