Manufacturing Quality Specialist ensures the quality and compliance of products throughout the oligonucleotide manufacturing process per ISO 13485, ISO 9001, and 21 CFR 820. This role will focus on implementing process control systems, conducting process audits, and supporting process improvements in the production environment. The Manufacturing Quality Specialist will work closely with cross-functional teams to uphold product standards, address nonconformities, and ensure regulatory requirements are met.
Key Responsibilities:
1. Customer Complaints and Product Returns Support:
- Provide support to customer complaints related to product quality, investigating issues, and collaborating with cross-functional team to provide timely solutions.
- Provide support to the management and testing of returned products, ensuring proper documentation and resolution of any quality concerns.
2. Quality Control Support
- Serve as a back-up QC technician as needed.
- Perform Final QC checks on VIP and Special Project orders.
3. Manufacturing Process Audits:
- Perform regular audits of manufacturing processes for risk mitigation, regulatory compliance, and continuous improvement.
- Implement corrective actions based on audit findings and ensure timely resolution of identified issues.
4. Process Improvement:
- Collaborate with production and engineering teams to identify and implement continuous improvement initiatives aimed at enhancing product quality and efficiency.
- Participate in process optimization and equipment validation efforts to improve overall manufacturing processes.
5. Nonconformance and CAPA Management:
- Identify, document, and manage nonconformances during the manufacturing process.
- Lead investigations into quality issues and conduct root cause analysis to identify underlying problems.
- Manage Corrective and Preventive Actions (CAPA) to resolve issues and prevent recurrence.
- Verify effectiveness of implemented actions within a given timeframe.
6. Quality Metrics and Reporting
- Monitor key performance indicators (KPIs) to measure the effectiveness of manufacturing process controls.
- Generate and present manufacturing process KPI reports to management, highlighting trends, areas for improvement, and corrective actions.
7. QMS Support
- Supports QMS tasks as assigned, such as Document Control Reviews, Training Module Reviews, Change Management, etc.
- Champions Good Documentation Practices through daily audits.
8. Cross-Functional Support:
- Provide training to production staff on quality standards, procedures, and best practices.
- Act as a resource for manufacturing teams, providing guidance on quality-related issues.
- Perform quality control testing and final product documentation review as needed.