Perfect QA Role for a Self-Starter
This key quality assurance position requires a strong background in quality assurance and good manufacturing practices (GMP). You will take ownership of quality assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards.
Key Responsibilities:
* Oversight of quality management system (QMS) areas, including deviation investigations, change control, corrective action and preventative action (CAPA) management, internal audits, and vendor management.
* Act as a quality assurance point of contact for operations, providing guidance on manufacturing, validations, and new product introductions.
* Management of schedules for GMP documentation review to support batch release, technology transfers, and new product timelines.
* Development, review, and approval of standard operating procedures (SOPs) and other key documentation.
* Application of quality risk management principles to drive compliance and efficiency.
* Leadership of cross-functional operations workstreams, collaborating with teams like quality control, quality assurance, manufacturing, and engineering.
* Drive continuous improvement initiatives and support external audits.
Requirements:
* A third-level qualification in a relevant science or engineering discipline.
* Experience working in a quality assurance role (minimum 3 years) 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.