Quality Assurance Specialist
Job Summary:
We are seeking a highly skilled Quality Assurance Specialist to ensure the quality and integrity of our products. The ideal candidate will have a strong understanding of GMP and regulatory compliance standards.
Key Responsibilities:
* Lead or assist with investigations into product or process non-compliance.
* Review and audit completed batch records and manufacturing logs.
* Perform quality checks on operational documentation (e.g., SOPs, work instructions, risk assessments).
* Conduct incoming raw material checks and maintain product status as required.
* Support stability program activities (e.g., sample pulls, protocol generation, weekly checks).
* Administer quality logs (e.g., QA Hold, Sample Requests).
* Lead daily compliance walkarounds on the operations floor.
* Support continuous improvement initiatives related to operational compliance.
* Provide additional quality support as required.
Requirements:
* A third-level degree in a science, quality, or engineering discipline.
* A minimum of 3 years' experience in a quality or operations role within a regulated GMP environment.
* Experience in biologics manufacturing and/or aseptic processing is highly desirable.
* Excellent communication and documentation skills.
* Ability to work independently with attention to detail and problem-solving skills.
* Comfortable supporting daily operational quality needs and decision-making within quality systems.