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Quality Records Specialist

4 weeks ago

Summit, New Jersey, United States Innova Solutions Full time
Job Title: Quality Records Specialist

Innova Solutions is seeking a highly skilled Quality Records Specialist to join our team. As a Quality Records Specialist, you will play a critical role in ensuring the quality and integrity of our products.

Key Responsibilities:
  • Process external deviation and change records from Contract Test Laboratories (CTL)
  • Coordinate testing of samples for lot release, PPQ, PSQ, and compile vendor documentation to generate a CoA/CoT
  • 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
  • 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
  • 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:
  • Preferred Bachelor's degree in a relevant scientific discipline or 3 years' experience in biotherapeutics/biomanufacturing QC/QA
  • Experience with deviation and change control management, preferably with Infinity systems
  • Advanced project management skills, including process excellence/six sigma methods and approaches
  • 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)
About Innova Solutions:

Innova Solutions is a global leader in technology and business transformation solutions. We employ approximately 50,000 professionals worldwide and report an annual revenue approaching $3 Billion. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields.

We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us.