QC Supervisor – Raw Materials

Job Description

The QC Supervisor – Raw Materials manages the Raw Materials laboratory and a team of seven lab analysts, ensuring accurate, compliant, and timely testing of all incoming raw materials used in GMP manufacturing. This role provides hands-on leadership, oversees day-to-day laboratory operations, and ensures that testing meets regulatory, quality, and organizational standards while supporting staff development and operational excellence.

Responsibilities

• Lead and manage the Raw Materials laboratory and a team of seven lab analysts, providing clear direction, coaching, and support.
• Organize, schedule, and oversee testing of all incoming raw materials used in GMP manufacturing to ensure timely completion.
• Ensure successful performance of raw material testing by monitoring workflow, prioritizing tasks, and aligning resources with testing demands.
• Identify and remove obstacles that could delay completion of testing or assigned projects, ensuring on-time delivery of results.
• Review testing documentation for accuracy, completeness, and compliance with Good Documentation Practices (GDP).
• Review and revise raw material specifications, standard operating procedures (SOPs), and related documentation to maintain compliance and continuous improvement.
• Train new hires on department processes, procedures, tools, and laboratory techniques to ensure consistent and compliant testing practices.
• Lead investigations into deviations, nonconformances, or out-of-specification results related to raw material testing, and drive appropriate corrective and preventive actions.
• Interact with auditors and clients during visits and tours, representing the laboratory and explaining processes, controls, and quality systems.
• Oversee daily activities of the group to ensure adherence to quality standards, testing priorities, and maintenance of schedules.
• Perform performance management for direct reports, including setting expectations, providing feedback, and supporting career development.
• Review and approve documentation generated by the team, including test results, reports, and related records.
• Drive organizational change within the team by developing and empowering staff, building effective and diverse teams, and fostering a culture of engagement and accountability.
• Promote innovation, collaboration, transparency, and team effectiveness within the Raw Materials lab.
• Manage timelines and coordinate work schedules for employees to align with testing needs and project deadlines.
• Conduct or oversee verifications and qualifications for new testing methods and new client requirements related to raw materials.
• Perform other job duties as assigned to support the broader quality control and manufacturing operations.

Essential Skills

• Bachelor’s degree in biological science, chemistry, or a related field is required.
• Minimum of three years of experience leading people, such as in a team lead or supervisory capacity.
• Minimum of three years of experience in raw materials testing or similar experience in the pharmaceutical industry, with a total of at least five years of relevant laboratory experience.
• Experience with USP compendial raw material testing, including wet chemistry and titrations.
• Hands-on experience performing wet chemistry testing and colorimetric titrations.
• Experience with EP, JP, and USP testing for raw materials.
• Pharmaceutical and GMP experience, including work in a cGMP environment.
• Knowledge of GMP regulations and their application in a cGMP manufacturing setting.
• Knowledge of raw materials sampling techniques and sampling plans.
• Ability to drive functional, technical, and operational excellence within a laboratory environment.
• Ability to manage timelines and coordinate work schedules for laboratory staff.
• Strong ability to review and interpret laboratory data and documentation for accuracy and compliance.
• Demonstrated leadership skills in developing and empowering staff, building effective teams, and driving engagement.
• Strong communication skills to interact effectively with auditors, clients, and internal stakeholders.

Additional Skills & Qualifications

• At least 3 years of prior supervisory or lead experience is preferred.
• Experience with analytical techniques such as HPLC is beneficial, with a preference for candidates who have raw materials USP testing experience.
• Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
• Experience leading investigations into deviations a