The Director, Quality Operations is responsible for the following areas:- Business Administrator for Trackwise Digital- Overseeing the Quality Assurance Operations group responsible for Manufacturing and Packaging areas.- Overseeing the Quality Assurance Batch Release group.- Overseeing the Pharmacovigilance group.

The Quality Assurance Manager was directly involved in the development, management and/or execution of the following areas:- Deviation/investigation reports. - Batch release of finished products.- In process testing of pharmaceutical products.- Environmental monitoring of viable particles within the production facility.- Cleaning validation program: assessment of products, development of protocols, management of product matrix and analytical method development. - Environmental systems program that monitors the temperature, humidity and pressure differentials of critical cGMP areas and investigates any deviations outside established acceptance criteria.• FDA inspections and assisting in customer audits.

As Compliance Supervisor, I was responsible for administrating or supervising the following areas:- Health and Safety: creating standard operating procedures (SOPs), performing internal audits, Tier II reporting, creating product material safety data sheets (MSDS) and conducting respirator fit tests.- Cleaning Validation: developing analytical methods, creating sampling protocols, maintaining the product matrix, assessing new products and performing equipment sampling.- Environmental Monitoring: sampling of the production facility, creating program procedures and executing deviation/investigation reports.- Calibration Program: assigning equipment asset numbers, issuing calibration work orders and entering executed calibration work orders.• General Compliance responsibilities: assisting in FDA and customer audits, creating SOPs, reviewing/approving change controls, supporting process validation activities and assisting in vendor compliance requirements.

As Senior Compliance Specialist, I was responsible for the following areas:• Managed the calibration program. Responsibilities included creating calibration SOPs, assigning equipment asset numbers, issuing calibration work orders, managing overdue calibration requirements and entering executed work orders.• Overhauled the cleaning validation program by creating a product matrix, revising program procedures and developing TOC (Total Organic Carbon) method validations.• Developed the environmental monitoring program by creating and executing qualification protocols, gathering microbial samples and generating program procedures.• Supported the Process Validation by reviewing newly issued batch records for validation requirements, creating validation protocols, performing statistical evaluations of data using Statgraphics software and generating Annual Product Reviews (APRs).• Supported the Compliance Specialist position by reviewing vendor qualification files, conducting complaint investigations and assisting in customer audits.

As the Validations Engineer and DEA Specialist, I was responsible for the following areas:• Performed equipment installation and operation qualifications.• Created and executed process validations for active pharmaceutical ingredients (APIs).• Completed DEA ARCOS reporting for controlled substances.• Generated DEA year end reports.• Managed controlled substance inventory transactions, DEA Form 222 requests and quota requests.