Mariana Oncology
Senior Quality Assurance Specialist, RLT Manufacturing Operations
Watertown, Massachusetts · Senior
Sponsorship not specifiedDetected 44 days ago
Supply ChainGMPFDA RegulatoryLeadership
About the role
- Batch Record Review & Product Release Review executed batch records, analytical data, and supporting documentation for radiopharmaceutical intermediates and finished products.
- Author and review CAPAs, change controls, and risk assessments.
- Ensure manufacturing areas remain in a state of compliance and inspection readiness.
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.
- 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.
- Maintain GMP documentation, SOPs, and controlled forms.
- Prepare for and support internal audits, regulatory inspections (e.g., FDA, EMA), and corporate quality assessments.
- Identify and drive improvements in processes, documentation, and compliance across radioligand operations.
- Support implementation of new equipment, facility upgrades, and process changes.
- This position provides QA oversight to daily operations, supports batch review and release, manages deviations and CAPAs, and partners closely with manufacturing, QC, manufacturing sciences & technology, and radiological safety teams to maintain a robust, inspection-ready quality culture.
Requirements
- 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.
- Ability to work collaboratively with cross functional teams including manufacturing, quality control, supply chain, technical development, and facilities personnel.
Skills
- Experience working with radiopharmaceuticals and/or oncology will be considered as a plus.
- Experience supporting aseptic operations, isotopes/radioligands, or PET/SPECT radiopharmaceutical environments preferred.
- Mariana Oncology 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.
- Mariana may change the published salary range based on company and market factors.
- Mariana Oncology's Principles
- Building a Legacy
- Execution Excellence
- Courage of our Convictions
Compensation
- 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.
Company info
- We are seeking an experienced Senior QA Specialist, RLT Manufacturing Operations to join Mariana's Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals.
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This listing is sourced directly from Mariana Oncology's careers page and normalized into a canonical job model.