QC Analyst III

As a QC Analyst III at Katalyst Healthcares & Life Sciences, your responsibilities include performing testing for In-Process, Lot Release, and Stability studies, conducting investigations and validations, and ensuring compliance with data integrity principles. You'll also manage quality records, support method transfers, and collaborate on project planning, ensuring that all processes meet our high-quality standards.

Candidates for the QC Analyst III position at Katalyst Healthcares & Life Sciences are required to possess at least an Associate’s Degree in Microbiology, Biochemistry, or a related scientific field. Experience in a GMP-regulated environment and knowledge of laboratory quality systems are preferred, along with strong problem-solving and communication skills.

Essential skills for a QC Analyst III at Katalyst Healthcares & Life Sciences include strong attention to detail, problem-solving abilities, excellent verbal and written communication, and proficiency with laboratory software. A solid understanding of GMP regulations and quality control processes is also crucial.

Katalyst Healthcares & Life Sciences ensures quality in testing through strict adherence to GMP and quality systems, such as TrackWise and LIMS. QC Analysts III are responsible for reviewing assay results, managing quality records, and implementing data integrity principles to maintain compliance and accuracy.

As a QC Analyst III at Katalyst Healthcares & Life Sciences, you can expect a positive and collaborative work environment. Your role will involve working with a dedicated team, contributing to problem-solving and project planning, and fostering a culture of quality and accuracy in laboratory testing.

In response to this question, you're encouraged to highlight specific experiences you've had in GMP-regulated labs, focusing on the importance of compliance and quality control in your previous job roles.

Discuss strategies you've implemented to maintain accuracy, such as double-checking results, following standard operating procedures, and making use of lab equipment correctly.

Outline a systematic process for troubleshooting, including checking the test methods, reviewing data entry for errors, and collaborating with team members to find solutions.

Provide a specific example where you noticed a deviation, explain how you addressed it, and outline the steps you took to report and rectify the issue promptly.

Share your insights on developing training materials or sessions that cover essential QC processes, ensuring that new hires understand quality expectations right from the start.

Discuss examples of effective collaboration, like regular team meetings, open communication channels, and how you help foster a positive team culture focused on quality.

Explain your understanding of data integrity, including how it impacts compliance, reliability of results, and the importance of maintaining accurate records in laboratory settings.

Provide insight into your organizational skills and methods you utilize to prioritize tasks, such as creating checklists or using digital tools to keep track of deadlines.

Be honest about a specific mistake, what you learned from the experience, and the corrective actions you took to prevent it from happening again.

Share your personal motivation for maintaining quality, such as a commitment to patient safety or a passion for scientific integrity, highlighting your dedication to excellence in your work.