Quality Control Specialist

Quality Control SpecialistThe Quality Control Specialist supports the manufacturing of radiopharmaceutical products by performing chemistry manipulations in a GMP environment, executing analytical testing, and ensuring regulatory compliance throughout the production process. This role focuses on process manufacturing, preparation of production materials and supplies, maintenance of general production equipment, and active participation in quality systems to help deliver safe, compliant, and reliable radiopharmaceutical products.Responsibilities:Carry out production responsibilities to meet established manufacturing schedules and ensure on-time delivery of radiopharmaceutical products.Perform chemistry manipulations and related laboratory activities in a GMP environment to support radiopharmaceutical production.Ensure regulatory compliance of production protocols within manufacturing operations and adhere to applicable quality and safety standards.Execute analytical methods and procedures for testing GMP-manufactured radiopharmaceutical products to verify quality and consistency.Prepare and submit required production, testing, and quality reports in a timely and accurate manner.Support and execute deviation reports, out-of-specification (OOS) investigations, root cause analyses, and corrective and preventive actions (CAPA).Optimize and validate methods and procedures for radiopharmaceutical products to improve efficiency, robustness, and compliance.Assist with creating, reviewing, and maintaining standard operating procedures (SOPs) for use in production and quality control activities.Assist with the preparation of regulatory submissions by providing technical data, documentation, and subject matter input.Assist with general laboratory cleaning, supply management, and routine maintenance of lab equipment and instrumentation.Assist with waste management activities, including handling and disposal of materials in accordance with safety and regulatory requirements.Perform other related duties as assigned to support production, quality control, and continuous improvement initiatives.Essential Skills:Associates degree in chemistry, biochemistry, chemical engineering, or a related field.Minimum of 2 years of related experience in a pharmaceutical manufacturing environment, with preference for radiopharmaceutical experience.Prior experience in pharmaceuticals, preferably in a quality or production position.Experience in a radiopharmaceutical environment is highly desirable.Hands-on experience in laboratory, chemistry, or chemical engineering settings.Experience in radiopharmaceutical or pharmaceutical manufacturing and quality control.Working knowledge of GMP (Good Manufacturing Practice) requirements and their application in production and testing.Experience with HPLC and other laboratory instrumentation used in analytical testing.Familiarity with aseptic techniques and cleanroom operations.Experience with instrument qualification, calibration, validation, and troubleshooting of lab equipment.Understanding of isotopes, radioactive materials, radiation safety, and nuclear medicine or radiopharma processes.Strong analytical skills with the ability to interpret data and support investigations.Excellent communication skills, including technical writing for reports, SOPs, and documentation.Proficiency with computer/PC-based systems used for data entry, documentation, and reporting.Ability to handle responsibilities in a fast-paced manufacturing environment while maintaining accuracy and compliance.Demonstrated ability to work effectively as part of a team.Thorough understanding of project management principles as applied to manufacturing and quality activities.Excellent organizational skills and strong attention to detail.Additional Skills & Qualifications:Experience working with radiopharmaceutical or nuclear medicine products.Exposure to cyclotron operations, radioactive materials handling, or related isotope production activities.Experience in cleanroom environments and aseptic manufacturing processes.Familiarity with radiation safety practices and regulations.Experience supporting deviation management, OOS investigations, root cause analysis, and CAPA implementation.Experience contributing to regulatory submissions for pharmaceutical or radiopharmaceutical products.Comfort with troubleshooting lab equipment and instrumentation issues.Ability to adapt to evolving processes, technologies, and regulatory expectations.Work Environment:This role is fully onsite at a manufacturing and laboratory facility located at Grissom Air Force Base in Bunker Hill, Indiana. The environment includes GMP production areas, laboratories, and cleanroom spaces where radiopharmaceutical products and radioactive materials are handled under strict safety and quality protocols. Team members work with laboratory instrumentation such as HPLC systems and other analytical equipment, as well as general production equipment that requires routine maintenance and calibration. The setting is fast-paced and schedule-driven, with work aligned to manufacturing timelines and quality control testing requirements. Employees follow defined safety procedures, radiation protection guidelines, and cleanroom practices, including appropriate use of personal protective equipment and controlled attire suitable for GMP and cleanroom operations.Job Type & Location:This is a Contract to Hire position based out of Indianapolis, IN.Pay and Benefits:The pay range for this position is $30.00 - $35.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)Workplace Type:This is a fully onsite position in Indianapolis, IN.Application Deadline:This position is anticipated to close on Oct 20, 2026.