Senior Quality Assurance Specialist, RLT Manufacturing Operations

Breadth of Responsibilities

• Provide on-the-floor QA support for radioligand manufacturing, including aseptic processing, sterile filtration, radiolabeling, and final product packaging.
• Perform line clearances, room/ equipment release, and real-time production record review.
• Ensure adherence to GMP, ALCOA+ data integrity principles, and radiation safety requirements.
• Review executed batch records, analytical data, and supporting documentation for radiopharmaceutical intermediates and finished products.
• Support disposition of raw materials, components, and finished radioligand batches.
• Lead or participate in investigations related to deviations, OOS/OOT results, complaints, and environmental/aseptic events.
• Author and review CAPAs, change controls, and risk assessments.
• Maintain GMP documentation, SOPs, and controlled forms.
• Prepare for and support internal audits, regulatory inspections (e.g., FDA, EMA), and corporate quality assessments.
• Ensure manufacturing areas remain in a state of compliance and inspection readiness.
• Identify and drive improvements in processes, documentation, and compliance across radioligand operations.
• Support implementation of new equipment, facility upgrades, and process changes.
• Promote a strong quality and safety culture with emphasis on radiological safety and GMP rigor.

Requirements/Skills

• Bachelor’s or Master’s degree in relevant scientific or engineering discipline with at least five years of experience working within Quality Assurance in the pharmaceutical or biotechnology industry.
• Experience working with radiopharmaceuticals and/or oncology will be considered as a plus.
• Experience with working in and implementing a global QMS adhering to EU GMP Vol 4 Part I, IV, and applicable EU GMP Annexes (including but not limited to Annex 1 and Annex 3), 21 CFR 210-212, 21CFR Part 11, ICH, and USP requirements.
• Experience supporting aseptic operations, isotopes/radioligands, or PET/SPECT radiopharmaceutical environments preferred.
• Ability to work collaboratively with cross functional teams including manufacturing, quality control, supply chain, technical development, and facilities personnel.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.

Compensation Summary

The salary for this position is expected to range between $66,800 and $124,000 per year. Your compensation will also include a performance-based cash incentive. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and will be reviewed periodically upon joining Mariana Oncology. Mariana may change the published salary range based on company and market factors.