Senior Quality Assurance Engineer

Curium Pharma; Noblesville (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Curium Pharma is seeking a Senior Quality Assurance Engineer to lead quality operations at the Noblesville, IN site. You will investigate exceptions, approve investigations, and drive continuous quality improvement and CAPA actions.

You will partner with cross-functional teams to ensure adherence to US and international guidelines, support regulatory audits, and maintain robust quality systems in a dynamic manufacturing environment.

Qualifications

• Experience applying RCA tools (5-Whys, Fishbone, TapRoot) to investigations.
• Familiar with US and international regulatory guidelines (FDA, ISO, cGMP).
• Strong knowledge of QA systems, audits, change control, and CAPA processes.

Responsibilities

• Review and approve Change Control and Quality Documents.
• Maintain compliance with FDA, HC, TGA, ISO, USP, NRC, cGMP guidelines.
• Review and approve validations for equipment, cleaning, and processes.

Skills

RCA techniques

5 Whys

Fishbone analysis

Kepner-Tregoe

TapRooT

Statistical tools

Regulatory compliance

Lean Six Sigma

Education

Bachelor Degree in Life Sciences or Engineering

Job description

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Senior Quality Assurance Engineer is the primary Quality Operations contact to ensure quality compliance for manufactured products onsite at our Noblesville, IN location. The Senior Quality Assurance Engineer investigates or approves exceptions / out of specifications with root cause analysis tools to ensure appropriate corrective actions are identified to reduce / prevent recurrence. The Senior Quality Assurance Engineer supports or initiates continuous quality improvement activities.

Work Schedule:

Monday - Friday 8am-5pm

Essential Functions

• Review and approve Change Control/Quality Documents involving product or process changes.
• 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.).
• Review and approve validations (equipment, cleaning and/or process) for assigned area.
• Prepares and participates in regulatory agency (i.e. FDA, HC, TGA, etc.) audits as well as internal audits.
• QA contact for risk management activities, including FMEA’s (Failure Modes and Effects Analysis).
• Investigate or serve as QA approver for customer complaints, exceptions / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented in the sites EQMS (Electronic Quality Management System).
• Assemble, analyze and report QA data to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Develop, review and/or revise SOP (standard Operating Procedures), BR’s (Batch Records), STM (Standard Test Methods), Specifications, FMEA’s.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.

Requirements

• Bachelor Degree in Life Sciences or Engineering required.
• 5 or more years of relevant experience required.
• Significant experience investigating exceptions and other variances, using Quality Engineering Tools and Techniques (i.e. RCA tools such as but not limited to 5-Whys, Fishbone/6M, TapRoot, Kepner-Tregoe, Comparative Analysis).
• Must be thoroughly familiar with applicable US and international regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
• Working knowledge of cGMP guidelines and their application in a controlled aseptic environment is strongly preferred.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Must have experience with statistical tools Certification in Lean or Six Sigma 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.

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.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.