Oversee all Quality functions for contract manufactured scientific products, ensuring adherence to established standards and regulations.
Produce and maintain Certificate of Analysis (CoA), Safety Data Sheets (SDS), and technical data documentation to accurately reflect product specifications and compliance requirements.
Handle Good Manufacturing Practice (GMP) audits, Corrective and Preventive Actions (CAPA), and Change Control processes to maintain quality standards and regulatory compliance.
Serve as a technical expert to answer product-related inquiries and provide support to internal teams and external stakeholders.
Collaborate with operations and sales departments to address quality-related issues and support business objectives.
Additional Responsibilities:
Conduct regular inspections and testing to ensure product quality and safety.
Implement and maintain the Quality Management System (QMS) to drive continuous improvement initiatives.
Lead investigations into quality issues and develop appropriate corrective actions.
Manage supplier quality and perform supplier audits as needed.
Qualifications:
Bachelor's degree in a scientific or engineering discipline preferred.
Experience in quality assurance/control within a manufacturing environment, preferably in the scientific products industry.
Strong knowledge of regulatory requirements, including GMP, FDA regulations, and ISO standards.
Excellent communication skills with the ability to effectively collaborate across departments.
Detail-oriented with strong analytical and problem-solving abilities.
Proficiency in Microsoft Word and Excel for documentation and data analysis.