The Senior Quality Control Testing Engineer 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.

• Perform Preventative Maintenance and Demand Maintenance on QC instruments and equipment
• Author and execute analytical method, and equipment/instrument IQ/OQ/PQ protocols.
• Coordinate with external contractors to facilitate instrument maintenance and repairs
• Author Standard Operating Procedures for new instruments/software
• While working in a cGMP environment, he/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, NRC, Health Canada, OSHA, 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.
• Authors Change Controls in Quality Management systems.
• Assists in training of laboratory personnel
• Perform routine testing to support the release of finished product, raw materials, API as needed

• Bachelor of Science Degree in Chemistry, or other science related field, preferred.
• 5 or more years of relevant experience in a cGMP environment required.
• Extensive knowledge of laboratory instruments/methods such as HPLC, GC, IC, ICP, FTIR, UV, wet bench methods, etc.

Preferred Experience:

• Lean Leader/Operational Excellence/5S
• Root Cause Analysis tools (Fishbone, 5 Why, Is/Is Not, etc.)

Working Conditions:

• Must work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Must be able to wear a variety of personal protective equipment.
• Able to work in a team-based environment across all functional groups.
• Close attention to detail required, must possess good hand-eye coordination.
• May be required to sit or stand for long periods of time while performing duties.
• Must be able to work outside of regular work hours.
• Able to remain calm in emergency situations while directing other employees
• Ability to follow procedures and enforce compliance with procedures
• Responsibilities also include the ability to lift (up to 70lbs), walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.