QC Supervisor

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 &…