Job Overview
As a Junior Quality Specialist, you will play a vital role in ensuring the quality of our products and processes. This is an exciting opportunity for someone to join our team as we continue to grow and innovate.
Main Responsibilities:
* Author high-quality notifications that meet regulatory requirements, ensuring clarity and accuracy.
* Develop and maintain key performance metrics related to quality notifications.
* Ensure timely completion of quality notifications and close on time.
* Manage the creation of incident reports and investigations documentation.
* Navigate document approval processes and collaborate with cross-functional teams.
Required Skills and Qualifications:
* Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
* At least 2 years' experience in the biotech industry (bulk manufacturing of pharmaceutical or biological components).
* Strong technical writing capabilities and previous experience authoring reports and investigations in a GMP environment.
PREFERRED SKILLS:
* Leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions.
* Supporting Regulatory Inspections and Site Internal Audits.
* Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.