Job Description

Job Title: QC Analyst III, Radiopharmaceuticals

Location: Brownsburg, Indiana, United States (No Sponsorship)

Department: Quality Control

Reports To: QC Manager / Supervisor

Position Summary:

My client is seeking an experienced and detail-oriented QC Analyst III to join their Quality Control team focused on radiopharmaceuticals. The ideal candidate will have in-depth knowledge of current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and regulatory guidelines, with proven experience in managing stability studies and handling rare radioactive materials in a pharmaceutical or radiopharmaceutical manufacturing environment on site in Brownsburg, Indiana, United States.

Key Responsibilities:

• Plan, organize, and manage stability studies in accordance with ICH and FDA guidelines.
• Review and analyze stability data, identify trends, and communicate findings effectively to internal stakeholders.
• Ensure all work complies with cGMPs, internal SOPs, and regulatory standards.
• Perform QC testing and analysis of radiopharmaceutical products, raw materials, and stability samples, ensuring data integrity and accuracy.
• Draft, review, and revise documentation including SOPs, protocols, and technical reports related to QC activities and stability programs.
• Handle and test rare radioactive materials in a safe and compliant manner, following established radiation safety protocols.
• Support investigations and implement corrective and preventive actions (CAPAs) related to QC deviations or non-conformances.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, and Regulatory Affairs.
• Maintain laboratory equipment, calibrations, and cleanliness per SOPs.

Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, or related field.
• Minimum 5+ years of experience in a QC role in a GMP-regulated environment, preferably in radiopharmaceuticals.
• Strong understanding of cGMPs, SOPs, FDA, and ICH guidelines.
• Hands-on experience with stability studies and data trending.
• Familiarity with radioactive material handling and radiation safety practices.
• Excellent written and verbal communication skills.
• Detail-oriented with strong organizational and analytical abilities.

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