A Quality Assurance Analyst in a biotech company ensures that products and processes meet stringent industry standards and regulatory requirements by conducting rigorous testing and validation. They develop and implement quality control procedures to maintain consistency, safety, and efficacy in biotech products. Their role also involves identifying potential defects, documenting findings, and collaborating with cross-functional teams to drive continuous improvement.
Validate laboratory data integrity compliance
Ensure strict adherence to data integrity compliance standards by meticulously validating laboratory data against regulatory and internal quality requirements. Monitor data collection processes to identify discrepancies and implement corrective actions to maintain accuracy and reliability. Collaborate with cross-functional teams to uphold documentation best practices and support audit readiness.
Develop and execute test plans for software systems
Develop and execute comprehensive test plans to validate software systems, ensuring functionality, performance, and security meet specified requirements. Analyze test results to identify defects and collaborate with development teams to implement effective solutions. Proficiency in automated testing tools and experience in Agile environments enhance the efficiency and accuracy of the testing process.
Monitor adherence to GMP (Good Manufacturing Practices)
Ensure strict compliance with Good Manufacturing Practices (GMP) by regularly inspecting production processes and documentation. Identify deviations promptly and collaborate with quality assurance teams to implement corrective actions. Maintain accurate records and provide detailed reports to support continuous improvement and regulatory inspections.
Audit quality control procedures and documentation
Evaluate and enhance audit quality control procedures to ensure compliance with regulatory standards and internal policies. Review documentation meticulously to identify inconsistencies and recommend improvements that increase accuracy and reliability. Implement best practices to maintain high audit integrity and support continuous quality improvement initiatives.
Identify, track, and report deviations and non-conformances
Monitor and document all deviations and non-conformances within operational processes to ensure compliance with quality standards. Utilize tracking systems to analyze trends and pinpoint root causes, enabling timely corrective actions. Provide detailed reports to management to support continuous improvement and maintain regulatory adherence.
Review batch records for accuracy and completeness
Reviewing batch records for accuracy and completeness ensures compliance with regulatory standards and maintains product quality. This role requires attention to detail and familiarity with GMP guidelines to identify discrepancies or errors promptly. Candidates should be proficient in documentation review processes and able to collaborate with quality assurance teams to resolve issues efficiently.
Ensure compliance with FDA and ISO regulations
Ensure strict adherence to FDA and ISO regulations by developing and implementing comprehensive quality control protocols. Regularly conduct audits and training sessions to maintain regulatory compliance and enhance process efficiency. Collaborate with cross-functional teams to address non-compliance issues promptly and integrate best practices for continuous improvement.
Coordinate root cause analysis for quality issues
Coordinate root cause analysis for quality issues by leading cross-functional teams to identify, investigate, and resolve non-conformances effectively. Utilize data-driven methodologies and quality management tools such as Six Sigma or Pareto analysis to pinpoint underlying problems and implement corrective actions. Ensure thorough documentation and follow-up to prevent recurrence, enhancing overall product reliability and customer satisfaction.
Support validation of instruments and equipment
Assist in the validation of instruments and equipment by conducting thorough testing and documenting results to ensure compliance with industry standards. Collaborate with quality assurance teams to identify discrepancies and recommend corrective actions that enhance accuracy and reliability. Maintain detailed records of validation protocols and support continuous improvement initiatives for calibration procedures.
Train staff on quality assurance protocols
Train staff on quality assurance protocols to ensure consistent product standards and reduce defects. Develop comprehensive training materials and conduct regular workshops to keep employees updated on industry best practices. Monitor staff performance and provide feedback to maintain high levels of compliance and operational excellence.