The QC Supervisor is responsible for leading and overseeing the Quality Control (QC) team to ensure accurate, reliable, and timely testing of raw materials, in-process samples, and final products for chromatography resins.

This role provides leadership in method validation, laboratory management, and continuous improvement of QC systems to maintain product quality and regulatory alignment.

The QC Supervisor acts as the key interface between QC, QA, Manufacturing, and R&D, ensuring effective communication, compliance with internal quality standards, and successful implementation of quality initiatives. The role includes coaching and developing QC personnel, planning resources, and ensuring adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Leadership & Management
1. Supervise daily QC operations and ensure all testing activities are executed in compliance with internal procedures and quality standards.
2. Plan, assign, and review the work of QC analysts to ensure testing accuracy, efficiency, and timely completion of batch release activities.
3. Develop and implement training programs to strengthen team competency and ensure method proficiency across analysts.
4. Manage resource planning, including manpower allocation, equipment utilization, and consumables management.
5. Conduct performance reviews, provide coaching, and build a high-performing QC team with strong ownership and accountability.
6. Supervises: Senior QC Analysts, QC Analysts, and QC Technicians
Quality System & Technical Oversight
7. Review and approve QC test results, data summaries, and reports for material release.
8. Oversee laboratory data integrity and ensure compliance with GDP and data control policies.
9. Drive continuous improvement initiatives for QC systems, test methods, and workflows to enhance reliability and efficiency.
10. Ensure proper investigation and documentation for out-of-specification (OOS) results, deviations, and nonconforming materials.
11. Maintain the QC laboratory environment in a state of readiness for internal and external audits.
Cross-Functional Collaboration
12. Partner with Manufacturing and QA to establish and maintain the Quality Control Plan aligned with production and product specifications.
13. Support product scale-up, process validation, and technology transfer by coordinating testing requirements and analytical support.
14. Serve as the QC representative in change control, CAPA, and risk assessment meetings.
15. Participate in supplier qualification and raw material inspection processes, ensuring compliance with material specifications.
Strategic and Continuous Improvement
16. Lead implementation of Statistical Process Control (SPC) for trend monitoring and continuous product quality improvement.
17. Support management in setting departmental KPIs and monitor performance against objectives.
18. Develop and maintain QC documentation, including SOPs, work instructions, and validation reports.
Other Related Responsibilities
19. Support audit preparation and participation (internal, customer, and third-party).
20. Act as deputy for QA or other quality functions when required.
21. Coordinate with global QC teams to align practices and share best practices.

Education & Training
• Bachelor’s or master’s degree in chemical engineering, materials engineering, chemistry, or other related fields.
Licensure & Certification
• CQT (Certified Quality Technician), or other quality-related professional certifications.
Knowledge, Skill, and Ability
• Proven ability to lead and mentor QC teams in a regulated or GMP-like environment.
• In-depth understanding of QC principles, method validation, and statistical quality control.
• Hands-on experience with analytical instruments such as SEM, FPLC, HPLC, FTIR, or particle analyzers.
• Strong knowledge of data integrity, GDP, and laboratory safety requirements.
• Excellent communication and cross-functional collaboration skills.
• Intermediate to advanced English proficiency (verbal and written).
Experience
• Minimum 5–7 years of experience in Quality Control in the bioprocessing, biomaterials, or medical device industry, including at least 2 years in a supervisory or team lead role.