Almac Group is a group of established businesses at the forefront of the Pharmaceutical industry. Our Company is a recognized global knowledge-based leader for the research, development and delivery of pharmaceutical services. Almac Group's services extend from drug discovery through all areas of clinical trials to the commercialization of pharmaceutical products. Our commitment to Discovery, Development and Delivery in conjunction with our long term partnerships with the majority of the world's leading pharmaceuticals guarantees a secure future for everyone.
Our Diagnostics division (DX) has an exciting opening for a Quality Assurance Specialist to join our talented team and help to support the continuing growth of our business. He/she will be responsible for ensuring compliance with CLIA/CAP certification requirements generated during and in support of the clinical testing service. In particular, to ensure that QA and validation activities are adequately planned, performed, and implemented on a continual basis as required by the company's quality policy and regulatory agencies.
Responsibilities include but are not limited to:
• Create, review and approve policies, procedures, work instructions, protocols and reports to ensure compliance with regulations including CLIA, CAP, and FDA in collaboration with Craigavon Quality and Durham Operations teams
• Review compliance to existing procedures by completion of internal quality audits and make recommendations for improvement where appropriate.
• Review quality control and calibration data to confirm compliance with approved methods and procedures
• Ensure that opportunities for continuous improvement are identified by ensuring that systems such as Corrective Action and Change Control Procedures are maintained, notified, implemented and satisfactorily closed out in accordance with written procedures.
• Maintain metrics for quality systems including: supplier quality, non-conformances, and CAPA
• Ensure that all necessary quality records have been completed and reviewed/approved by responsible personnel
• Day-to-day supervision of the document control system ensuring that the identification, traceability and distribution of approved documents such as SOP's and specifications are controlled.
• Participate in maintenance of the supplier quality program, including create/maintain quality agreements, perform audits per audit schedule and ensure supplier corrective actions
• Support employee training program to ensure effective training and compliance with regulations
• Prepare QA reports, where necessary, on activities assigned by the Head of Quality and/or Director of Operations