What are the responsibilities and job description for the Quality specialist position at Joulé?
Job Title : Quality Records Specialist Location : Summit, NJ Hours / Schedule : Mon- Fri Business hours Type : Contract Overview Leading pharmaceutical company looking for an experienced Quality Records Specialist.
Ideal candidates should have experience with deviation and change control management, preferably with Infinity systems. Responsibilities Initiation, facilitation, and tracking of quality records Provide regular communication and metrics for status of quality records Effectively communicate issues, risks and proposed solutions within the organization Provide communication, support, and guidance to CTLs within the QA vector and upstream material team Other duties may include : Create and revise SOP Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT) Enter data and retrieve information from SharePoint and Smartsheet testing trackers Requirements Experience with deviation and change control management, preferably with Infinity systems Strong organizational skills, including ability to follow assignments through to completion Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams Detail oriented with demonstrated application in problem solving With moderate oversight from manager, think strategically and understand global impact of decisions Advanced project management skills such as process excellence / six sigma methods and approaches including process mapping, root cause analysis and problem definition Experience within the Cellular Therapeutics and / or gene-based products.
Last updated : 2024-11-19
