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