Senior Quality Control Testing Engineer

The Senior Quality Control Testing Engineer role is responsible for supporting analytical testing of raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with regulatory and company standards. This includes technical support and troubleshooting of instrumentation for reliability. This role is critical to maintaining product quality, supporting production timelines, and ensuring regulatory compliance.

Work Schedule: Monday - Friday 8am - 4:30pm

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Perform routine and non-routine analytical testing using techniques such as HPLC, GC, UV-Vis, FTIR, titration, ICP-MS etc.
• Conduct testing on raw materials, intermediates, and finished products in accordance with cGMP and SOPs.
• Review and interpret analytical data; prepare detailed and accurate reports and documentation.
• Maintain laboratory equipment, including calibration, qualification, and troubleshooting.
• Participate in method development, method validation, and stability studies as required.
• Ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal quality standards.
• Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
• Support or serve as lead investigator for Out of Specifications results, identify and implement Corrective Actions.
• Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc. Maintain a clean and organized laboratory environment and adhere to safety guidelines.
• Participate in audits and inspections and support documentation requests from regulatory authorities.

• Bachelor of Science in Biology, Chemistry or related field required.
• 5 or more years of relevant experience required.
• Solid knowledge of analytical techniques and instrumentation (HPLC, GC, ICP-MS, etc.).
• Familiarity with cGMP, GLP, and regulatory guidelines.
• Must be able to resolve problems, handle conflict and make effective decisions under pressure, and conduct Root Cause Analysis.
• Ability to do simple to complex math calculations, input data into the computer and analyze data as required.
• Ability to multitask projects.
• Must be proficient in use of Microsoft suite office products.
• Good computer skills, including utilizing personal computers and data entry programs Good hands on, analytical, and problem solving and decision making skills.
• Excellent writing and verbal communications skills.
• Ability to work independently and with others to accomplish goals and priorities High level of energy and regular, consistent attendance.
• Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing 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.