Quality Records Specialist

3 days ago


Summit, New Jersey, United States American Cybersystems Full time
Job Title: Quality Records Specialist

We are seeking a highly skilled Quality Records Specialist to join our team at Innova Solutions. As a Quality Records Specialist, you will play a critical role in ensuring the accuracy and completeness of quality records, facilitating timely release of products, and collaborating with cross-functional teams to drive quality excellence.

Key Responsibilities:
  • Process external deviation and change records from Contract Test Laboratories (CTLs)
  • Coordinate testing of samples for lot release, PPQ, PSQ, and compile vendor documentation to generate CoA/CoT
  • Partner 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 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, CoAs, and CoTs
  • 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, with biologics considered
  • 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)
What We Offer:
  • Competitive pay rate: $30 - $31 per hour
  • Benefits package, including medical, dental, vision, 401(k), HSA, FSA, life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and paid leaves
  • Opportunity to work with a global company with a strong presence in the industry
About Innova Solutions:

Innova Solutions is a leading provider of technology and business transformation solutions, with a global presence and a reputation for excellence. We are committed to delivering high-quality services and solutions to our clients, and we are seeking talented individuals to join our team.



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