Quality Specialist
2 months ago
Position: Quality Records Specialist 59670-1
Location: Summit NJ 07901
Duration: 12+ months (possibility of extension for the right candidate depending on performance)
Pay rate: $30/ hour on W2
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 compiling vendor documentation to generate a CoA/CoT.
This role will partner cross-functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vectors 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 the 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 the manager, think strategically and understand the 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 product 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 Bachelor's in a relevant scientific discipline, or 3 years experience in biotherapeutics/biomanufacturing QC/QA
DUTIES AND RESPONSIBILITIES:
• Initiation, facilitation, and tracking of quality records
• Provide regular communication and metrics for the 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 an office environment.
• Sitting, standing, and computer work is required.
• Ability to participate in conference calls
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