Job Description
Perfect QA Role for a Self-Starter
We are seeking a highly skilled Quality Assurance professional to join our team. In this key QA position, you will be responsible for ensuring the quality and compliance of our biological products in accordance with Good Manufacturing Practice (GMP) and regulatory standards.
The ideal candidate will have a strong background in Quality Assurance and GMP, with excellent knowledge of QMS procedures, batch-related documentation, root cause investigations, and change control processes.
Key Responsibilities:
* Oversee Quality Management System (QMS) areas, including Deviation Investigations, Change Control, CAPA management, Internal Audits, and Vendor Management.
* Serve as a QA point of contact for Operations, providing guidance on manufacturing, validations, and new product introductions.
* Manage schedules for GMP documentation review to support batch release, tech transfers, and new product timelines.
* Generate, review, and approve Standard Operating Procedures (SOPs) and other key documentation.
* Apply Quality Risk Management principles to drive compliance and efficiency.
* Lead cross-functional Operations workstreams, collaborating with teams like QC, QA, Manufacturing, and Engineering.
* Drive continuous improvement initiatives and support external audits.
Requirements:
* Third-level qualification in a relevant Science or Engineering discipline.
* Minimum 5 years of experience in a GMP Quality environment.
* Strong technical writing, organizational, and problem-solving abilities.
* Excellent collaboration and communication skills across departments.
What We Offer:
A competitive salary of $ $120,000 - $150,000 per year, depending on experience.