Role Summary
The Quality Compliance Specialist will join the team within a monoclonal antibody manufacturing facility, supporting Good Manufacturing Practice (GMP) quality compliance and ensuring audit readiness. This position is part of a small, dynamic, and highly capable group focused on delivering outstanding performance in safety, quality, supply, and cost. Collaboration with other departments and sites will be essential.
Key responsibilities for the Quality Compliance Specialist include:
* Supporting and managing projects and initiatives focused on identifying and implementing improvements in quality and compliance standards.
* Developing, monitoring, maintaining, and enhancing systems and processes for Quality compliance.
* Driving the rollout of facility-wide quality initiatives.
* Providing guidance and support to colleagues and cross-functional teams with documentation, compliance concerns, and systems.
* Proactively working to achieve timely and accurate completion of records, investigations, and related actions.
* Tracking and analyzing metrics and trends to raise compliance standards and meet expectations of both internal and external auditors.
* Leading and aiding in quality investigations and ensuring timely resolution and closure of associated actions.
* Updating documentation as needed in relation to change requests, manufacturing processes, and cleaning, while ensuring alignment with global regulatory standards.
* Taking a leadership role in developing and continually improving departmental systems such as documentation lifecycle management, training, SOPs, and process flows.
* Directing compliance inspections, audits, and facilitating the generation and analysis of metrics.
* Ensuring adherence to Data Integrity and ALCOA principles.
* Overseeing documentation practices for equipment validation, commissioning, SOP oversight, and staff training.
* Providing technical assistance and advice on IT compliance and documentation platforms.
* Collaborating with Quality Control (QC) subject matter experts to optimize audit readiness activities.
Basic Qualifications
* BSc in a science discipline (Microbiology, Chemistry, Biochemistry, or related area preferred) and a minimum of 5 years' relevant experience.
Qualifications/Skills, Knowledge & Experience
* Exceptional attention to detail and commitment to sound documentation practices.
* Strong understanding of current GMP standards and related GxP regulations (highly desirable).
* Experience with quality management systems.
* Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
* Experience within Quality Control laboratory settings is an advantage.