Quality Control Supervisor

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

Position Summary

The Quality Control (QC) Supervisor is responsible for ensuring that technical operations and production lines run efficiently, consistently producing high-quality products that meet all regulatory and customer requirements. The role involves coordinating employee efforts, facilitating communication between management and production teams, and ensuring compliance with quality standards. The QC Supervisor will play a key role in overseeing Environmental Monitoring (EM) activities, supervising third-party lab testing, and acting as the primary QC point of contact for local operations. The role may involve hands-on laboratory work and assay execution as required.

 PRIMARY RESPONSIBILITIES (include but are not limited to). 

• Supervise the execution of compendial and internal methods, including third-party testing.
• Ensure timely and accurate completion of laboratory work according to schedules developed with input from global leadership.
• Draft, review, and oversee the development, qualification, and validation of protocols with appropriate guidance.
• Ensure that all work performed under protocols is accurate, well-documented, and meets reporting standards.
• Maintain high-quality documentation in compliance with regulatory guidelines and site/global Standard Operating Procedures (SOPs).
• Execute and supervise procedures or methods of moderate complexity, ensuring high-quality outcomes.
• Review and approve work completed by team members to ensure quality, accuracy, and completeness.
• Analyze data trends and monitor method performance regularly.
• Identify and document quality/compliance gaps during lab work (e.g., Out of Specification [OOS]/Out of Trend [OOT]) and take appropriate actions.
• Draft technical documents with guidance as required.
• Participate in and oversee training activities, ensuring that all methods are executed competently after training.
• Draft and execute On-The-Job (OJT) training forms.
• Oversee the execution of the laboratory cleaning schedule to maintain compliance.
• Communicate effectively with third-party testing sites as needed.
• Assist in the execution of efficiency and compliance improvement projects with guidance from senior management.

COMPETENCIES & PERSONAL ATTRIBUTES

• Strong alignment with Cryoport’s mission and values.
• A proactive change agent who collaborates effectively and challenges the status quo when necessary.
• Exceptional communication skills, with the ability to inspire and influence at all organizational levels, build consensus, and drive change aligned with corporate culture.
• Strong organizational, planning, and analytical skills with a focus on process improvement.
• Detail-oriented with a high degree of accuracy and the ability to prioritize tasks effectively.
• Demonstrates a strong business process orientation when developing solutions.
• High ethical standards, integrity, and a commitment to quality.
• Collaborative team player who supports and champions the company culture.
• Strong work ethic with the ability to deliver results in a dynamic environment.
• Basic understanding of instrument operations and troubleshooting across multiple techniques in Microbiology and Cell Therapy.
• Proficiency with Microsoft Office Suite and other relevant software.
• Strong written and verbal communication skills in English.
• Ability to manage multiple tasks effectively under pressure to meet deadlines.
• Ability to sit, stand, walk regularly, and occasionally lift up to 40 pounds.
• Willingness to embrace continuous personal and professional development.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Bachelor’s degree or higher in Biotechnology, Biomedical Sciences, or a related field.
• Minimum of 3 years of experience in the cell therapy or pharmaceutical industries.
• Ability to lift at least 25 pounds.