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Beacon Hill Life Sciences is looking for an experienced QA professional to perform assigned quality assurance activities in compliance with applicable SOPs and cGMPs.
Essential Functions
- Ensure completion of required training, work (including document review, batch release, QA on-the-floor, AQLs), and timely release of materials and batches.
- 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.).
- 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 for the 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 with safety/Quality guidelines and SOPs.
- Ensure the maintenance of the department, premises, and equipment.
- Ensure that all assigned training is carried out so that assigned tasks are performed confidently and consistently.
- Perform all work in compliance with site safety and radiation protection guidelines.
- Collaborate with team members to ensure assigned tasks are completed on time. Must demonstrate flexibility in adjusting to changing priorities and schedules.
- Attend mandatory trainings as required by site regulatory requirements and management.
- Assist with quality investigations to determine root cause and applicable CAPAs.
- Perform other general duties associated with the position as required by supervision.
Requirements
- Associate degree in life science or a related field, with completion of 4 college-level life science courses required. Bachelor’s degree in life science or a related field preferred. Work experience is considered instead of a degree.
- 3+ years of relevant experience required.
- Experience with computer data entry required; must be proficient in Microsoft Office.
