What are the responsibilities and job description for the Quality Records Specialist position at Axelon?
Pay Range : $25 / hr - $30 / hr
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 :
Experience with Clinical and / or Commercial products manufacture, supply and post-approval change management
Experience managing external suppliers and other supply chain issues
Education and Experience : - Preferred Bachelors in relevant scientific discipline, or 3 years' experience in biotherapeutics / biomanufacturing QC / QA
DUTIES AND RESPONSIBILITIES :
WORKING CONDITIONS (US Only) :
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
dditional Job Requirements :
None
Salary : $25 - $30
