Principal Quality Assurance Technician Job Details | curium

About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve : An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

Perform and be responsible for Quality Assurance activities in order to comply with applicable SOP's and cGMPs. Will coordinate and oversee the work of others. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Manage projects using cross-functional teams.

Schedule : Sunday-Wednesday 4am - 2 : 30pm

Essential Functions

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).
• Ensure completion of required training, work (including document review, batch release, QA on-the-floor, AQLs), and timely release of materials and batches.
• Responsible for the thorough and efficient review and disposition of completed batch record documentation ensuring adherence to Good Documentation Practices / cGMPs and applicable local procedures.
• Responsible for performing and / or overseeing performance of Quality Assurance on the floor tasks including but not limited to performing AQL inspections, performing clearances for manufacturing areas and providing Quality input and guidance to manufacturing personnel.
• Responsible for dispositioning finished product, raw materials / components and intermediates through an all-inclusive documentation review and cross-reference of electronic quality systems.
• Responsible with release of incoming raw materials and components per applicable local procedures. This may include support for labeling dispositioned raw materials and components with appropriate status indicator labels.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety / Quality guidelines and SOP's.
• Ensure the maintenance of department, premises and equipment.
• Ensure that all assigned training is carried out to competently perform assigned tasks confidently and consistently.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Collaborate with other team members to ensure assigned tasks are performed in a timely manner.
• Must demonstrate flexibility in adjusting to changing priorities and schedules.
• Attend mandatory trainings as required by site regulatory requirements and management.
• Perform other general duties associated with the position as required by supervision.

Requirements

Working Conditions :

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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