Manager Quality Control Technical Services

About the Role

The Manager Quality Control Technical Services (QCTS) is responsible for the end-to-end lifecycle management of QC laboratory instruments and related computerized systems, including qualification, calibration, maintenance, change control, and decommissioning within a GMP environment. This position oversees the Maryland Heights, MO, and Noblesville, IN sites and manages three direct reports at the Maryland Heights facility and one direct report at the Noblesville, IN facility.

Responsibilities

• Oversight of Preventative Maintenance and Demand Maintenance on QC instruments and equipment.
• Manages outside service providers and service contracts to support preventive maintenance, repair activities, and qualification services.
• Author/Approve analytical method, and equipment/instrument IQ/OQ/PQ protocols, Standard Operating Procedures, Change Controls, etc.
• Ensure computerized systems and analytical data remain compliant with data integrity expectations.
• Maintain operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
• Author Change Controls, Protocols, Corrective and Preventive Action items, and Periodic Reviews.
• Assure compliance with department training and qualification.
• Work safely with radioactivity and ensure all direct reports maintain ALARA and manage their daily activities to meet quarterly ALARA goals.
• Provide technical counsel concerning the scientific content of methods, analytical testing of samples, evaluation and interpretation of laboratory results, and other QC-related issues.
• Authors Change Controls in Quality Management systems.
• Ability to lift up to 70 pounds, kneel, crouch, twist the upper body, walk, bend, stoop, push, pull, and reach; physically negotiate stairs and evacuation ladders with or without accommodation.
• Wear and operate safety equipment, enter vessels, and inspect equipment.
• Use material handling devices (e.g., hand truck, fork truck, conveyors) and proper lifting techniques to prevent injury.
• Wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• Sit or stand for long periods of 8+ hours a day while performing duties.
• Work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable, and toxic materials, dust, dirt, odors, and irritants.
• Complete safety training within allotted timeframes and work in a team-based environment.
• Work outside of regular work hours, including off-shift, weekends, and holidays as business needs require.

Requirements

• Bachelor of Science Degree in Chemistry or other science-related field, preferred.
• Twelve or more years of experience in QC laboratory operations, analytical instrumentation, or technical services in a regulated environment.
• Two or more years of supervisory experience.
• Strong knowledge of GMP, data integrity, calibration, qualification, and equipment lifecycle management.
• Experience managing outside vendors, maintenance providers, and service contracts.
• Demonstrated ability to author and review SOPs, protocols, reports, and technical documentation.
• Experience supporting deviations, CAPAs, change controls, investigations, and audits.
• Strong project management, problem-solving, and cross-functional collaboration skills.
• Familiarity with computerized systems and analytical data platforms used in QC laboratories.
• Ability to prioritize multiple projects and support instrument uptime in a fast-paced environment.
• Good hand-eye coordination and close attention to detail.
• Willingness to work in a plant producing radioactive materials and participate in safety programs designed to minimize potential and/or actual exposure levels.