A Quality Control Manager in a biotech company ensures that all products meet rigorous industry standards and regulatory requirements through systematic testing and validation. They oversee laboratory procedures, implement quality management systems, and coordinate with cross-functional teams to address any deviations or non-conformities. Their role is critical in maintaining product integrity, safety, and compliance throughout the manufacturing process.
Oversee implementation of quality control protocols and SOPs
Oversee implementation of quality control protocols and standard operating procedures (SOPs) to ensure product consistency and compliance with industry regulations. Monitor daily operations to identify deviations, conduct audits, and implement corrective actions that maintain high-quality standards. Collaborate with cross-functional teams to update and improve SOPs for enhanced efficiency and accuracy.
Manage laboratory testing of raw materials and finished products
Oversee the laboratory testing process for raw materials and finished products to ensure compliance with quality standards and regulatory requirements. Implement standardized testing protocols, analyze results for accuracy, and maintain detailed documentation for traceability. Collaborate with production and quality assurance teams to promptly address any deviations or quality issues and recommend improvements.
Ensure compliance with regulatory standards (FDA, EMA, ISO)
Ensure strict adherence to regulatory standards including FDA, EMA, and ISO by systematically monitoring and updating company protocols. Implement comprehensive compliance audits and provide training programs to keep the team informed about evolving regulations. This role requires proactive management to mitigate risks and guarantee alignment with international quality and safety requirements.
Lead root cause analysis for deviations and non-conformities
Lead root cause analysis for deviations and non-conformities by systematically identifying underlying issues and implementing corrective actions to prevent recurrence. Utilize data-driven investigation techniques and collaborate with cross-functional teams to ensure compliance with quality standards and regulatory requirements. Drive continuous improvement initiatives that enhance process reliability and product quality within the organization.
Conduct internal audits and quality assessments
Conduct regular internal audits and quality assessments to ensure compliance with company standards and regulatory requirements. Analyze audit findings to identify areas for process improvement and risk mitigation. Collaborate with departments to implement corrective actions and enhance overall operational efficiency.
Supervise QC team training and performance evaluations
Oversee the Quality Control (QC) team by conducting comprehensive training programs to enhance skills and ensure adherence to industry standards. Regularly evaluate individual and team performance through structured assessments to identify growth opportunities and address gaps. Implement continuous improvement strategies to maintain high-quality production and compliance with company policies.
Approve or reject materials and products based on quality results
Review and analyze quality control data to approve or reject materials and products, ensuring compliance with industry standards and company specifications. Maintain accurate records of inspection results and collaborate with production teams to address quality issues promptly. Implement quality assurance protocols to enhance product reliability and customer satisfaction.
Review and analyze QC data trends for continuous improvement
Review and analyze QC data trends to identify patterns, inconsistencies, and areas for quality enhancement. Utilize statistical tools and software to interpret data accurately and recommend actionable improvements. Collaborate with cross-functional teams to implement corrective measures that drive continuous process optimization and product excellence.
Coordinate with cross-functional teams (R&D, Production, QA)
Coordinate with cross-functional teams including R&D, Production, and Quality Assurance to ensure seamless project execution and alignment with company goals. Facilitate effective communication and collaboration to troubleshoot issues, streamline processes, and meet product development milestones. Drive continuous improvement by integrating feedback from all departments to optimize workflow efficiency and product quality.
Prepare and maintain quality documentation and reports
Prepare and maintain quality documentation and reports accurately to ensure compliance with industry standards and regulatory requirements. Develop organized record-keeping systems that facilitate easy access and retrieval of information for audits and reviews. Collaborate with teams to update documentation regularly, improving process transparency and supporting continuous quality improvement initiatives.