Associate Principal QA Specialist

• Provide QA review and oversight for various studies and activities
• Support a culture of quality and continuous improvement within QC and Development Services
• Support Operations to ensure ongoing compliance with GMP
• Manage and support GMP issues through QMS processes, site governance and senior QA leadership
• Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site
• Support senior QA leadership in driving continuous improvement and ensuring processes are 'fit for purpose'
• Ensure compliance with GMP requirements within Development Services
• Maintain compliance with Regulatory Authority expectations, Global Quality Standards and customer requirements
• Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records
• Review QA activities for MSAT studies, pilot studies, and Development Services
• Review QC activities including method validation, reference standards and stability studies
• Manage and escalate critical compliance issues through the QMS
• Conduct audit trail reviews
• Perform area walkthroughs to identify and resolve non-compliance
• Audit raw data, protocols and validation reports for GMP compliance
• Maintain and promote audit readiness
• Ensure protocols and validation reports are approved according to project schedules
• Lead process audits and support GMP audit activities
• Identify and participate in continuous improvement initiatives
• Support quality governance via Local Quality Councils and project meetings
• Provide QA SME support for Operations, QC, MSAT and Development Services
• Mentor and coach business partners in GMP practices
• Advise scientists on documentation and follow-up expectations
• Provide out-of-hours QA support where required
• Act as a GMP SME enforcing site quality processes
• Perform additional duties as assigned

• Education/Degree: Field of Study Scientific
• Work Experience: Quality (QA or QC) Level- Advanced - 5-10 years
• QA Manufacturing experience
• TrackWise records experience (Deviations, Change controls, CAPA's, investigations)
• OOS investigations

Audit experience