Completed investigations on process documentation errors and expired bulk hold times for a solid dosage pharmaceutical manufacturer. Performed gap assessments comparing parameters in approved cleaning validation studies with related cleaning instructions for compounding and packaging equipment as part of an FDA observation response for a semi-solid pharmaceutical facility. Reviewed and approved cleaning verification, validation protocols and final reports for a major pharmaceutical facility. Verified the adequacy of documentation in support of 483 observation responses for a solid dosage manufacturing company.

Responsible for completing laboratory investigations in Global Quality Management System (GQMS) for out of specification and aberrant results for utilities, raw materials and in-process samples. Tracked over action and over alert results for utility and environmental samples. Provided support for the validation and qualification of laboratory equipment and manufacturing areas. Revised Standard Operating Procedures and Test Methods. Provided data and support for audit requests.