Theranostics Quality Assurance Specialist

PHARMALOGIC HOLDINGS•New York, NY

11h

About The Position

Join our team at the forefront of precision medicine. As a Theranostics QA Specialist, you’ll be part of a team bringing innovative radiopharmaceutical treatments from the lab to patients who need them most. The Theranostics QA Specialist is responsible for Quality Assurance support for manufacturing operations, focusing on aseptic processing, terminal sterilized products, sterility assurance, and contamination control. This role ensures compliance with phase appropriate current Good Manufacturing Practices (cGMP), internal procedures, and regulatory requirements while driving continuous product quality and operational excellence improvement.

Requirements

Bachelor’s degree in a scientific discipline preferred
3-5 years of radiopharmacy manufacturing or equivalent experience
Excellent communication and collaboration skills with all stakeholders, including Quality, PET Manufacturing, and Pharmacy.
Ability to work varying shifts both independently and as part of a team and be reachable at all hours.
Strong knowledge of a GMP manufacturing environment and working with FDA and FDA cGMP regulations required.
Experience with quality systems, deviation/investigation management, change control, and CAPA.
Ability to analyze complex problems, identify root causes, and drive corrective actions.
Excellent project management, critical thinking, and problem-solving skills required to manage competing projects, timelines, and deliverables.
A passion for continuous learning and curiosity to find innovative ways to improve our ways of working.
Required are a mechanical aptitude, manual dexterity for manipulating small items; ability to lift between 16 and 50 lbs., and to handle frequent crawling, stooping, crouching, and kneeling

Nice To Haves

Knowledge of molecular imaging techniques and pharmaceutical study design and execution is desired.
Experience with laboratory procedures, radiochemistry techniques, analytical methods, equipment (HPLC, GC, TLC, and radiometric measures), radiochemistry synthesis, US FDA cGMP, Radiation Safety Principles, Isotopes production, and analytical equipment troubleshooting is highly favored.

Responsibilities

Provide quality oversight for all sterile manufacturing operations, including aseptic processing, terminally sterilized processes, and related support areas.
Manage the QA program to provide coverage and decision-making support across a variable radiopharmaceutical manufacturing schedule, including off-shift and potential weekend operations as needed.
Ensure the integrity of sterile product manufacturing through robust sterility assurance practices.
Manage QA review and approval of cGMP documentation, including procedures, protocols, deviations, out of specifications, CAPAs and change controls.
Collaborate with cross-functional departments (Manufacturing, QC, Engineering, Safety, Regulatory, etc.) to resolve quality-related issues and support new products and product lifecycle management.
Promote a proactive quality culture focused on patient safety, product quality, and regulatory compliance.
Perform other job-related duties as assigned