Principal QA Technician

Description:

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. Ability to manage projects using cross-functional teams.

Ensure that all assigned training is carried out to competently perform assigned tasks confidently and consistently.

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.