Quality Records Specialist at Axelon Services Corporation

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