WorkSource Oregon Senior QA Specialist in BEND, Oregon

Senior QA Specialist - Bend, Oregon Where You Get To Live! Our client is located in beautiful Bend, Oregon, the mountain town that has it all! Located in the in the shadows of the Cascade Mountains and surrounded by numerous lakes and rivers, Central Oregon is an outdoor enthusiasts'paradise. Check out the sights and sounds of Bend at: http://www.youtube.com/watch?v=u6zSKJqalug#at=20 What You Get To Do! *Lead and coordinate all client inspections *Manage the internal audit program *Lead the document prep room during all inspections *Manage CAPA implementation due to outcomes from inspections *Issue and manage inspection reports *Perform external supplier audits *Support implementation and continuous improvement of Quality Systems *Controlled document and record review and approval, with primary focus on SOP's followed by Validation, Master Production Records, analytical test records, analytical methods, method validation, and data review *Assist with investigations and root cause analysis *Implement corrective and preventive action, as needed *Coordinate and collate department quality metrics and participate in reporting to upper management What You Will Need: *BA or BS degree in a scientific discipline (at minimum) *8+ years of experience in pharmaceutical/biotechnology or related industry *5 years of experience in Quality Assurance *Prior experience managing CAPA implementation *Experience with controlled document and record review and approval, with primary focus on SOP's followed by Validation, Master Production Records, analytical test records, analytical methods, method validation, and data review *GMP regulations knowledge/experience (FDA, EMEA, IPEC, ISO etc.) required *Independent and flexible - able to readily adapt to changing priorities in a fast-paced cutting edge environment *Must be able to travel one week per month *Support an environment of teamwork and development *Demonstrated attention to detail and excellent oral and written communication skills