Quality Assurance Specialist
3 days ago
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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