Quality Assurance Specialist

The Quality Assurance Specialist is responsible for performing the following duties as directed by the Manager, Quality Assurance.

RESPONSIBILITIES

• Independently perform a wide range of activities to support the Quality Assurance department by participating in the processes required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organisation.
• Serve as Quality Assurance contact for assigned customers & functional areas (as required).
• Support the promotion and compliance with regulations, guidelines, and Standard Operating Procedures within the organisation.
• Serve as a resource promoting the development of understanding of the key elements related to Quality Management Systems & regulatory compliance requirements including training opportunities to staff at an organisational wide level.
• Maintain current awareness of all required standards, laws & guidelines.
• Provide input to the development of Quality Assurance Standard Operating Procedures & processes, the Quality Manual and other organisational Standard Operating Procedures & processes where required.
• Provide support and input to development groups for consultation & interpretation of regulations, guidelines, corporate standards & policies.
• Prepare for, carry out, report and follow up on Quality Assurance required audits – including internal, 3rd party and vendor audits.
• Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits.
• Participate in review of root cause analysis, corrective action & preventive action plans for internal, 3rd party & vendor audits.
• Responsible for ensuring assigned internal audit & vendor audits are completed as scheduled and reporting associated metrics to Quality Assurance management.
• Monitor the compliance of all departments via routine audits to ensure adherence with internal Standard Operating Procedures & external regulations.
• Participate in and support client, regulatory and sub-contractor audits.
• Support the processes in place to ensure customer complaints are appropriately raised and handled.
• Support the processes in place to ensure internally identified Quality Issues are appropriately raised and handled.
• Provide oversight & participate in review root cause analysis, corrective action & preventive action plans for Quality Issues & customer complaints.
• Provide oversight to the documentation, reporting, effectiveness checks & closure of compliance issues (audits, Quality Issues & customer complaints).
• Participate in monthly laboratory Quality Assurance meetings.
• Assist the Manager, Quality Assurance as required.
• Provide support to Quality Assurance management with customer-initiated audits & mock regulatory inspections & regulatory facility inspections.
• Participate in Lean/Six Sigma, process improvements.
• Support Quality Assurance related activities to ensure a harmonised Quality Management System.
• Participate in Continuous Professional Development.
• Perform the role of a Deputy Archivist when required.

REQUIRED QUALIFICATIONS

• Bachelor’s Degree in scientific discipline required or requisite experience.
• Minimum 3 years’ experience in Laboratory Quality Assurance, Pharmaceutical or Clinical Research Organization (CRO) is required.
• Knowledge of, and demonstrated experience with application of, regulatory agencies.
• Knowledge of, and demonstrated experience with application of Good Clinical Practice (GCP) guidance is required.

PREFERRED QUALIFICATIONS

• Knowledge of applicable regulations and standards such as ISO15189, NEQAS, CAP and CLIA is strongly preferred.

PHYSICAL REQUIREMENTS:

• S - Sedentary Work - Exerting up to 10 pounds of force occasionally. Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.