Quality Records Specialist

11 hours ago


Jersey City, New Jersey, United States Hays Recruitment Full time
Job Title: Quality Records Specialist

Our client is seeking a Quality Records Specialist to partner with cross-functional teams to ensure timely release of quality records for commercial, clinical, and early development programs.

Key Responsibilities:
  • 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, 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 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
  • Ability to think strategically and understand global impact of decisions
Preferred Qualifications:
  • Advanced project management skills, including process excellence and six sigma methods
  • Experience within the Cellular Therapeutics and/or gene-based products
  • Knowledge of applicable FDA/EMA regulations in the biotechnology industry
  • Experience managing external suppliers and other supply chain issues
Benefits:
  • Full medical benefits, dental benefits, vision benefits, 401K, and Life Insurance

This is a contract/temporary role with Hays Recruitment, offering a unique opportunity to work with a professional recruiter and gain experience in the industry.



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