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 years’ experience in bio therapeutics / bio manufacturing QC / QA
DUTIES AND 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
WORKING CONDITIONS (US Only) :
- May be required to work in office environment.
- Sitting, standing and computer work is required.
- Ability to participate in conference calls.