HospiraQA Data Reviewer, Stability Coordinator, Analyst III
Jan. 2006 - May. 2013Boulder Colorado• Quality Control Analyst, testing raw material, in-process and final product API data, and stability samples, and development work. Promoted to Stability Coordinator with the responsibility of entire stability program and migrated from a three-product site to a 14-15 product site. Represented stability during FDA audit with no 483s. Wrote Investigations, Exception, Corrective Action Preventive Actions reports, change controls, and standard operating procedures. Gathered information for corporate in response to the FDA oversite committee issues during a later audit that required remediation. Saved the company from three significant errors before the FDA audit. Two were major software issues and one a spreadsheet calculation mistake, all giving inaccurate results, involving months of data. Coordinated and participated in the quality training program. At the end, involved in remediation.