Senior Quality Assurance Specialist, RLT Manufacturing Operations
About The Position
We are seeking an experienced Senior QA Specialist, RLT Manufacturing Operations to join Mariana’s Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals. The Senior QA Specialist for Radioligand GMP Manufacturing Operations plays a critical role in ensuring that radiopharmaceutical products are manufactured, tested, and released in full compliance with cGMP, radiation safety regulations, and applicable global quality standards. 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
- Position is a hybrid role with 4 days a week attendance required in the Watertown manufacturing facility to perform onsite QA activities related to cGMP manufacturing and quality control testing.
- 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 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.
- 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.
Nice To Haves
- 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.
Responsibilities
- GMP Operations Oversight
- 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.
- Batch Record Review & Product Release
- 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.
- Quality Systems Management
- 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.
- Inspection and Audit Readiness
- 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.
- Continuous Improvement
- 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.
- Training and Leadership
- Serve as a subject matter expert (SME) in radiopharmaceutical GMP requirements, aseptic operations, and radiation-handling quality considerations.
- Train manufacturing and QC personnel on quality systems, deviations, and compliance standards.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
