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Quality Records Specialist

1 month ago

Summit, United States Joulé Full time

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. Experience with biologics will be considered.

Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management
Knowledge of applicable FDA/EMA regulations in the biotechnology industry
Experience managing external suppliers and other supply chain issues
Experience with Quality Systems (change control, deviation and investigation)

Preferred Bachelors in relevant scientific discipline, or 3 years’ experience in biotherapeutics/biomanufacturing QC/QA



Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.