Vacancy expired!
Piper Companies is looking for a Quality Assurance SME to support a growing Development Quality, Biologics division to manage the development and implementation of Quality Processes and Systems for a Cell Therapy Manufacturing organization in Gaithersburg, MD. Responsibilities for the Quality Assurance SME include: • Perform record review in cGMP manufacturing environment • Support review of batch records, methods, and validation protocols/reports • Participate in quality investigations and evaluations of quality records • Hands-on QA support and oversight to internal staffQualifications for the Quality Assurance SME include: • Bachelor's of Science Degree in a scientific/technical field (Chemistry, Biology, Microbiology, Engineering, etc.) • 10 years experience within the Pharmaceutical Industry with 3 years experience working in GMP industry supporting Cell & Gene Therapy • Experience with investigations, reviews of quality events; CAPAs, Deviations, change control, etc. Compensation for the Quality Assurance SME include: • 6 - 12 month consulting assignment • Subsidized benefits through Piper Companies (Medical, Dental, Vision) for duration of consulting assignment Keywords: Quality Assurance, Quality Control, SOPs, Work Instructions, batch review, batch record review, investigations, deviations, cell therapy, biologics GMP, Good Manufacturing Practices, Change Control, Electronic Document Management System, trackwise, Veeva
Vacancy expired!