Job Summary:
We are seeking a highly motivated and experienced Quality Assurance Specialist to join our team at Biologics Ballytivnan.
The successful candidate will be responsible for ensuring that all products manufactured at our site meet the required standards for marketed and investigational drug products. This includes providing quality and compliance oversight, reviewing batch records and manufacturing logs, and completing quality reviews of operations documentation.
The ideal candidate will have a third-level degree in a science, quality, or engineering discipline and a minimum of three years' experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing and aseptic processing is highly desirable.
This is a full-time position working on-site, with a 2-cycle shift pattern from Monday to Friday. The week will alternate between days and evenings.
Key Responsibilities:
* Ensure all products meet marketing and investigational drug product standards
* Provide quality and compliance oversight to the Operations function
* Review Batch Records and Manufacturing Logs
* Complete quality reviews of operations documentation
* Lead investigations into non-compliance issues
Requirements:
* Third-level degree in science, quality, or engineering
* Minimum 3 years' experience in quality/operations in GMP environment
* Biologics manufacturing and aseptic processing experience (desirable)
* Strong knowledge of regulatory requirements