Summary of PositionThe 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.
Essential Functions - 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, qualification services
- Author/Approve analytical method, and equipment/instrument IQ/OQ/PQ protocols, Standard Operating Procedures, Change Controls, etc.
- Ensuring computerized systems and analytical data remain compliant with data integrity expectations.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- 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 accordingly to ensure they meet their quarterly ALARA goals.
- Provides technical counsel concerning the scientific content of methods, analytical testing of samples, evaluation and interpretation of laboratory results, and other QC related issues as required.
- Authors Change Controls in Quality Management systems.
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 required.
- Two or more years of supervisory experience required.
- 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.
Working Conditions: - Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels
- Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
- Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury
- Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed
- May be required to sit or stand for long periods of 8+ hours a day while performing duties
- Must possess good hand-eye coordination; close attention to detail is required
- Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment
- Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require
Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Job Segment: QC, Facilities, Information Technology, IT Manager, Medical Technologist, Quality, Operations, Technology, Healthcare
