Senior Quality Engineer

Theragenics Corp•Buford, GA

About The Position

Be part of a mission that matters,join Theragenics as a Senior Quality Engineer and help drive the production of life‑saving radiopharmaceuticals used in cutting-edge cancer treatments. In this critical role, you’ll provide quality oversight and technical leadership for radioisotope development programs, process scale‑up, and commercial production operations. Your work will directly support Drug Master Files (DMFs) and pharmaceutical supply chains, ensuring compliance with cGMP and ISO standards while contributing to therapies that improve and extend lives. Company Overview At Theragenics, we’re passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what’s possible, ensuring a brighter future for patients everywhere. Leader in minimally invasive medical devices for cancer, vascular, and surgical applications Headquarters in Atlanta, Georgia, with facilities in Costa Rica, Texas, and Massachusetts Proud operator of Arrotek, a U.S. and Ireland‑based consultancy pioneering minimally invasive solutions Role Summary As a Senior Quality Engineer, you’ll ensure radioisotope production and development activities comply with FDA regulations (21 CFR Parts 210, 211, and 212), ISO quality system standards, and internal quality policies. You’ll collaborate with radiochemistry, cyclotron operations, engineering, regulatory affairs, health physics, and manufacturing teams to maintain compliance and drive continuous improvement.

Requirements

Bachelor’s degree in chemistry, Chemical Engineering, Biomedical Engineering, Radiochemistry, Pharmaceutical Sciences, Biological Sciences, or related field
A Minimum of 5 years of experience in quality engineering, quality assurance, or validation within regulated environments
Experience working with radioisotope production, radiochemistry, pharmaceutical manufacturing, or nuclear materials strongly preferred
Experience supporting Drug Master File (DMF) submissions or pharmaceutical regulatory filings preferred
Experience supporting process validation, equipment qualification, and GMP documentation
Strong knowledge of cGMP and regulated quality systems (FDA, ISO, pharmaceutical, or medical device)
Working knowledge of radiochemistry, radioisotope production, or nuclear materials handling preferred
Experience with risk management methodologies, deviation investigations, and CAPA systems
Strong technical writing and documentation skills supporting regulated manufacturing environments
Ability to translate development activities into compliant production documentation and regulatory support packages
Strong project management and cross-functional communication skills
Proficiency with Microsoft Office and electronic quality management systems

Responsibilities

Ensure compliance with 21 CFR Parts 210 and 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and/or 21 CFR Part 212 (Current Good Manufacturing Practice for Positron Emission Tomography Drugs) where applicable to radioisotope production activities
Support implementation and maintenance of quality systems consistent with pharmaceutical cGMP requirements, including documentation control, deviation management, CAPA, and change control
Provide quality oversight for radioisotope production, purification, packaging, and distribution processes to ensure compliance with regulatory expectations and internal procedures
Participate in internal audits and regulatory inspections, including preparation of documentation and responses to regulatory observations
Develop, review, and approve SOPs, batch production records, validation protocols, qualification documentation, and technical reports supporting radioisotope production
Ensure production and development documentation complies with data integrity and recordkeeping requirements defined in 21 CFR 211 Subpart J
Support development and maintenance of master batch records and production documentation for isotope production processes
Lead or support validation and qualification activities for radioisotope production processes in accordance with 21 CFR 211.100 and 211.110 requirements for process validation and in-process controls
Develop and execute validation protocols for equipment, manufacturing processes, and analytical methods
Support qualification of production equipment, hot-cell systems, and laboratory instrumentation used in isotope processing
Generate and review validation reports to ensure compliance with regulatory expectations
Provide quality input into the preparation and maintenance of Drug Master Files (DMFs) and other regulatory submissions associated with radioisotope production and supply
Conduct risk assessments and hazard analyses to support development and production activities involving radioactive materials
Investigate deviations, nonconformances, and out-of-specification events related to radioisotope production processes
Perform root cause analysis and implement corrective and preventive actions (CAPA) to maintain compliance and product quality
Work closely with radiochemistry and cyclotron operations teams to support development and scale-up of new isotope production processes
Provide quality oversight during technology transfer from research and development to commercial production
Support continuous improvement initiatives related to process robustness, compliance, and operational efficiency