Job Summary:
The Manufacturing Quality Specialist is an individual contributor responsible for managing change control records and leading projects that support Manufacturing Operations. This role is vital in monitoring and reporting deviations, change controls, and improvement projects to ensure compliance and operational excellence in biopharmaceutical manufacturing.
Key Responsibilities:
- Own and manage change control records, CAPAs (Corrective and Preventive Actions), Periodic Review documents, and Standard Operating Procedure (SOP) revisions.
- Support the monitoring and reporting of deviations and change controls, ensuring timely resolution and compliance with regulatory requirements.
- Identify areas for continuous process improvement, applying operational excellence tools to reduce process variability and deliver measurable efficiency gains.
- Lead simple to moderate cross-functional projects, ensuring that project goals are met within the defined scope. Influence peers to achieve common objectives and maintain focus during project meetings.
- Write and maintain technical documents, including SOPs, protocols, and deviation reports, ensuring clarity and compliance with cGMP (current Good Manufacturing Practice) standards.
- Assist in the preparation for audits and inspections, ensuring all documentation and processes meet regulatory expectations.
Qualifications:
- Bachelor’s Degree with a focus in Biopharmaceuticals or a related field.
- Minimum of 2 years of experience in a cGMP environment within the biopharmaceutical or pharmaceutical manufacturing industry.
- Preferably experience as a manufacturing operator or technician.
- Knowledge of cGMP systems and regulations from various regional jurisdictions.
- Familiarity with change controls, deviations, project management, and audit/inspection processes.
