Occupation:Clinical Quality Assurance |
Location:Croydon, PA |
Education Level:Bachelor |
Will Relocate:YES |
Description
SUMMARY OF QUALIFICATIONS: Capable and accomplishment driven individual, with over 20 years of experience in the Pharmaceutical / Drug Development Industry. A flexible problem solver with excellent written and interpersonal communication skills and a dependable team member at both associate and management levels with recognized achievements in the following areas: * Operational experience and management in Primary and Secondary Clinical Packaging * Operational experience in Facilities administration including Capital Assets Management (CAM) and Building Monitoring Systems (BMS) * Knowledgeable in Quality Control / Quality Assurance inspection and auditing functionalities * Trained and Trainer in FDA regulated cGMPs Author and Trainer of related site SOPs * Experienced in investigations and report writing and implementation of corrective and preventative actions (CAPA) * Effective Cause Factor Analysis (ECFA) Trained. * DEA clearance to handle Controlled Substance Packaging * Environmental Health and Safety (EHS) related experience including safety training and compliance * Lean Six-Sigma business efficacy Team Member * Proficient in the following software: Microsoft Word, Excel and SharePoint. Siemens Insight BMS, CIMScan BMS, BSI