Quality Assurance Specialist

3 days ago


Summit, New Jersey, United States Axelon Full time
Job Title: Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team at Axelon. As a Quality Assurance Specialist, you will be responsible for processing external deviation and change records from our Contract Test Laboratories (CTL).

Your primary duties will include:

  • Initiating, facilitating, and tracking quality records
  • Providing regular communication and metrics for the status of quality records
  • Effectively communicating issues, risks, and proposed solutions within the organization
  • Providing communication, support, and guidance to CTLs within the QA vector and upstream material team

You will also be responsible for:

  • Creating and revising SOPs
  • Creating and revising Certificates of Analysis (CoA) and Certificates of Testing (CoT)
  • Entering data and retrieving information from SharePoint and Smartsheet testing trackers

This is a challenging and rewarding role that requires strong organizational skills, excellent verbal and written communication skills, and the ability to work in a fast-paced environment. If you are a detail-oriented individual with a passion for quality assurance, we encourage you to apply.

Requirements:

  • Bachelor's degree in a relevant scientific discipline or 3 years of experience in biotherapeutics/biomanufacturing QC/QA
  • Experience with deviation and change control management, preferably with Infinity systems
  • Strong organizational skills and ability to follow assignments through to completion
  • Ability to work in a fast-paced environment and meet deadlines

Working Conditions:

  • May be required to work in an office environment
  • Sitting, standing, and computer work are required
  • Ability to participate in conference calls


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