The Quality Control Instrumentation Manager is responsible for leading the implementation, and optimization of analytical instrumentation within the Quality Control department. This role involves hands-on project management through to operational readiness. The ideal candidate will possess a deep technical understanding of analytical techniques, project management skills, and the ability to work collaboratively with cross-functional teams to enhance our testing capabilities and ensure regulatory compliance. The Quality Control Instrumentation Manager provides technical counsel concerning the scientific content of methods, analytical testing, instrumentation, evaluation, and interpretation of laboratory data, assisting in OOS investigations, and other QC related issues as required.

• Lead cross-functional projects for the installation and qualification of new analytical instrumentation, ensuring projects are completed on time, within budget, and in compliance with regulatory standards.
• Perform Preventative Maintenance and Demand Maintenance on QC instruments and equipment Author and execute analytical method, and equipment/instrument IQ/OQ/PQ protocols.
• Collaborate with equipment vendors and service providers for procurement, installation, and troubleshooting of analytical instruments. Negotiate contracts and manage vendor relationships to support project goals.
• Author Standard Operating Procedures for new instruments/software
• Perform routine testing to support the release of finished product, raw materials, API
• 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.
• Assists laboratory personnel with the process of instrument repair and troubleshooting, qualification and validation, and training.
• Work closely with the quality control team, research and development, manufacturing, and external partners to ensure seamless integration of new instrumentation into existing processes. Provide training and support to staff on new equipment and methodologies.
• Ensure all analytical instrumentation and associated processes comply with regulatory requirements and industry best practices. Maintain accurate documentation and records for equipment validation, calibration, and maintenance.
• Develop and optimize analytical methods and testing processes for new equipment. Ensure robust, accurate, and efficient testing capabilities are established and maintained.

• Bachelor of Science Degree in Chemistry, or other science related field is required.
• Twelve or more years of relevant experience required including experience in a quality control or analytical laboratory setting, with at least three years in a leadership role managing analytical instrumentation projects.
• Strong technical knowledge of analytical instrumentation techniques and methods such as HPLC, GC, ICP, FTIR, UV, TLC, and Mass Spectrometry.
• Proven ability to manage complex projects, including scheduling, budgeting, and cross-functional team leadership.
• Familiarity with regulatory requirements and quality standards relevant to pharmaceutical or chemical manufacturing laboratories.
• Experience with equipment selection, installation, and method development.
• Lean Leader/Operational Excellence/5S preferred.
• Root Cause Analysis tools (Fishbone, 5 Why, Is/Is Not, etc.) preferred.

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.