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Exception Template - AFP- Sr. Associate Bioassay
Ref No.: 17-03347
Location: West Greenwich, Rhode Island
Start Date / End Date: 11/06/2017 to 11/05/2020
Senior Associate Quality Control Bioassay


•Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
•Operate and maintain specialized laboratory equipment and instrumentation
•Participate in laboratory investigations and audits as necessary
•Comply with safety guidelines, cGMPs and other applicable regulatory requirements
•Ensure facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
•Perform review and approval of procedures, assays, documents and records, including but not limited to Nonconformance records and CAPAs
•Support Continual Improvement initiatives, programs and projects
•Alert management of quality, compliance, supply and safety risks
•Support internal/external audits and inspections as needed
•Complete required assigned training to permit execution of required tasks

Basic Qualifications

•Master's Degree OR
•Bachelor's Degree and 2 years of Quality experience
OR
•Associate's degree and 6 years of Quality experience
OR
•High school diploma/GED and 8 years of Quality experience

Preferred Qualifications

•Experience in performing cell based analytical methods such as ELISA, bioassay and potency assays
•Demonstrated experience in investigations, change control, validation, audits, QC processes
•Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision
•Strong communication skills (both written and oral), facilitation and presentation skills