Quality Assurance Specialist

3 weeks ago


Summit, New Jersey, United States System One Full time
Job Summary

System One is seeking an experienced Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in deviation and change control management, preferably with Infinity systems.

Key Responsibilities

Initiate, facilitate, and track 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

Additional Responsibilities
Create and revise SOPs
Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
Enter data and retrieve information from SharePoint and Smartsheet testing trackers

Requirements

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 the ability to work within inter-disciplinary and cross-functional teams
Detail-oriented with demonstrated application in problem-solving
With moderate oversight from a manager, think strategically and understand the global impact of decisions
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)
Preferred Bachelor's in a relevant scientific discipline, or 3 years' experience in biotherapeutics/biomanufacturing QC/QA

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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