Job Title: Senior Quality Assurance Specialist
We are seeking an experienced and skilled Senior Quality Assurance Specialist to join our team at {company}. In this key QA position, you will take ownership of quality assurance activities to ensure biological products are manufactured in strict compliance with Good Manufacturing Practices (GMP) and regulatory standards.
Your responsibilities will include:
* Overseeing quality management system (QMS) areas including deviation investigations, change control, corrective action/preventive action (CAPA) management, internal audits, and vendor management.
* Acting as a quality point of contact for operations, providing guidance on manufacturing, validations, and new product introductions.
* Managing schedules for GMP documentation review to support batch release, technology transfers, and new product timelines.
* Generating, reviewing, and approving standard operating procedures (SOPs) and other key documentation.
* Applying quality risk management principles to drive compliance and efficiency.
* Leading cross-functional operations workstreams, collaborating with teams like quality control (QC), quality assurance (QA), manufacturing, and engineering.
* Driving continuous improvement initiatives and supporting external audits.
What We're Looking For:
A third-level qualification in a relevant science or engineering discipline.
At least three years of experience working in a QA role within a sterile GMP manufacturing environment.
Strong knowledge of QMS procedures, batch-related documentation, root cause investigations, and change control processes.
Exceptional problem-solving, technical writing, and organizational abilities.
A team player who is passionate about delivering high-quality results.