Job Description : 100% onsite required
Work schedule : Mon- Fri(normal business hours)
PURPOSE AND SCOPE OF POSITION :
The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL).
Other duties may include; Coordinate testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a Client CoA / CoT.
This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.
REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities :
- 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
DESIRED COMPETENCIES : Knowledge, Skills, and Abilities :
- 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)
Education and Experience : - Preferred Bachelors in relevant scientific discipline, or 3 years’ experience in biotherapeutics / biomanufacturing QC / QA