Job Title: Compliance Specialist III
Job Description:
As a QA Compliance Specialist III, you will play a crucial role in ensuring the quality and compliance of products manufactured at our state-of-the-art facility.
Key Responsibilities include:
* Leading investigations into product or manufacturing process non-compliance;
* Reviewing and auditing completed batch records;
* Reviewing manufacturing logs as required;
* Completing quality reviews of operations documentation (SOPs, JSTMs, Risk Assessments);
* Completing incoming raw material checks, including product status maintenance (as required);
* Providing stability program support, e.g., sample pulls, weekly checks, protocol generation (as required);
* Administering quality logs, e.g., QA hold, sample request;
* Leading daily walk-around inspections of manufacturing areas;
* Driving continuous improvements and simplifying site processes and procedures to ensure compliance at all times;
Required Skills and Qualifications:
The ideal candidate will possess:
* A third-level degree in a science, quality, or engineering discipline;
* Ideal previous experience in a quality role;
* A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment;
* Experience in biologics manufacturing is highly desirable;
* Experience in aseptic processing gained within either a quality or operations role is highly desirable;
* A strong knowledge of regulatory requirements;
Cognitive Skills:
The successful candidate will require:
* A high level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures at all times;