Results-driven Quality Control Analyst with extensive experience in pharmaceutical manufacturing and quality assurance, adept at ensuring compliance with cGMP and ALCOA+ standards. Expertise in analyzing finished products, in-process samples, and raw materials, with a proven track record in conducting audits and preparing comprehensive documentation. Strong collaborator with a focus on partnering with cross-functional teams to drive continuous improvement initiatives. Committed to fostering a culture of safety and environmental responsibility while training and mentoring staff to enhance operational excellence.
Support manufacturing through analysis of finished products, in-process samples, and raw materials per BAR specifications. Prepare reagents, standards, and samples for analysis following established methods. Apply hands-on knowledge of analytical instrumentation within QC. Ensure compliance with quality event records and laboratory procedures, maintaining data integrity with ALCOA+ principals. Participate in laboratory cleanliness, dispose of hazardous waste properly, and audit results regularly.
Operated manufacturing process equipment and handled materials effectively. Adhered to written procedures, ensuring accurate documentation per cGMP and Agilent SOP's. Executed various unit operations on raw materials, understanding computer systems for efficiency. Prepared equipment for maintenance while maintaining high housekeeping standards.
Coordinated internal training for new and existing Compression Technicians on high-speed compression equipment. Developed formal drafts of SOP's, CPC's, and MBR's for senior management approval. Implemented training programs for new technicians in processing, troubleshooting, set-up, and disassembly. Adhered to cGMP and Sandoz SOP's to document operations accurately.