Quality Assurance Specialist

1 week ago


Summit, New Jersey, United States Surnise Systems Inc Full time
Job Title: Quality Records Specialist

Job ID:
Location: Summit, NJ,
Duration: 12 Months contract 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 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:
  • 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:
  • 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 bio therapeutics/bio manufacturing QC/QA

Working Conditions (US Only):
  • May be required to work in office environment.
  • Sitting, standing and computer work is required.
  • Ability to participate in conference calls.


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