PharmaLogic · 13 hours ago
Theranostics Quality Assurance Specialist
Bronx, NY
Full-time
Onsite
Mid Level
$75K/yr - $85K/yr
3+ years expPharmaLogic is at the forefront of precision medicine, seeking a Theranostics Quality Assurance Specialist to support innovative radiopharmaceutical treatments. This role involves ensuring quality assurance for manufacturing operations, focusing on compliance with cGMP and continuous improvement in product quality and operational excellence.
Pharmaceuticals
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
Qualification
Required
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
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
Preferred
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
Benefits
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Life insurance
On-site parking
Paid time off
Vision care
Company
PharmaLogic
PharmaLogic is a leading global contract development and manufacturing organization (CDMO) specialized in diagnostic and therapeutic radiopharmaceuticals.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Keith Kennedy
Chief Financial Officer
Deborah Vanerka
Chief Revenue Officer (CRO)
Company data provided by crunchbase