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Quality Assurance Specialist

1 month ago

Akron, Ohio, United States Axelon Full time
Job Title: Quality Records Specialist

At Axelon, we are seeking a highly skilled Quality Records Specialist to join our team. As a key member of our Global Supplier Quality department, you will play a critical role in ensuring the quality and integrity of our products.

Job Summary:

The Quality Records Specialist will be responsible for processing external deviation and change records from our Contract Test Laboratories (CTL). This role requires strong organizational skills, attention to detail, and excellent communication skills.

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
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
Preferred Qualifications:
  • 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.
  • Knowledge of applicable FDA/EMA regulations in the biotechnology industry
  • Experience managing external suppliers and other supply chain issues
Working Conditions:

This role may require working in an office environment. Sitting, standing, and computer work are required. Ability to participate in conference calls.