Job Title: Product Quality Assurance Specialist
We are currently seeking an experienced Product Quality Assurance Specialist, to support the successful transfer and commercialization of new biologic products at a regulated manufacturing site. This role plays a critical part in ensuring new products are integrated into the site's Quality Management System, fully compliant with regulatory and company requirements.
Key Responsibilities:
* Evaluate quality risks associated with new product transfers from development through commercialization.
* Maintain quality system integration for all new product introductions, adhering to GMP guidelines.
* Collaborate closely with QA, CMC, R&D, Science & Technology, and other functional groups to ensure clarity of roles and compliance expectations.
A minimum of three years experience in a related discipline is required along with strong working knowledge of relevant regulatory standards. Effective communication skills will also be essential when interacting with cross-functional teams within this heavily governed environment. -----------------------------------