Top 3 Must Have Skill Sets:
Knowledge in Biopharmaceutical Drug Substances experience
Project manager and technical writing skills
Experience in owning investigations
Companies Rhode Island Operations is currently seeking a Manufacturing Specialist Investigator (External worker) in our site Investigation group. In support of companies mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug Substance Operations to ensure supply and to optimize the patient experience. The Manufacturing Specialist Investigator - conducts technical investigations from our clinical and commercial drug Substance Operations. This role understands the investigation process as well as manufacturing processes for the Rhode Island Facility. The Manufacturing Specialist Investigator owns major and trend deviations to support identifying root cause and will also participate in multi-functional idealization of design solutions (CAPAs). Also maintains close interaction with the Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate product impact and contribute to product/process improvement.
•Doctorate degree OR Master’s degree and 3 years of Bio pharmaceutical Operations experience OR Bachelor’s degree and 5 years of Bio pharmaceutical Operations experience
•2+ years of experience in investigation process industry experience, non academia within biopharm environment
•Must have previous technical writing experience, experience In investigation process (RCA) and Drug Substance Experience.
•Demonstrate understanding and application of Drug Substance process, data mining, Microsoft office tool, Quality and compliance.
•Strong technical writing and interpersonal skills (able to influence tri functional team and organizational leads)
•Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
•Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
"This posting is for Contingent Worker, not an FTE"