Quality Assurance Specialist

Job content

ACM Global Laboratories is a Global organisation that has a clear vision and core values to ensure that they deliver actionable clinical insights that lead to therapies ad treatments that provide health, healing and hope to patients around the world.

Our Quality Assurance team ACM has an opportunity for a Quality Assurance Specilaist to join the Quality team awithin our ACM Bioanalytical Services. The Quality Assurance Specialist promotes and supports a culture of audit readiness within ACM Bioanalytical Services. Responsible for the independent monitoring of the lab to assure compliance with Good Laboratory Practice and Good Clinical Practice, including but not limited to maintaining the Quality Assurance Systems in compliance with GLP and GCP, conducting a variety of audits including review/audit of Study Plans, Reports, procedural, process and Facility, managing Corrective Actions & Preventive Actions System(CAPA), reviewing, developing, maintaining and implementing Standard Operating Procedures (SOPs) and supporting customer audits & regulatory inspections. This role will also be required to act as Deputy Archivist. The Quality Assurance Specilaist reports to the Director, Quality Assurance at our York, UK site.

ATTRIBUTES

• Bachelor’s degree required, preferably in a science field.
• 3 years of quality assurance experience required; experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred.
• Knowledge of and demonstrated experience in Good Clinical Practice (GCP), Good Laboratory Practice, ISO15189, CAP, CLIA strongly preferred. Must have GLP experience.

RESPONSIBILITIES

• Quality Assurance: Manage all types of Quality Assurance required audits – including all types of internal & client audits and regulatory inspections. Maintain the QA Systems. Act as Deputy Archivist.
• Process Improvement: Support the operation in process improvement initiatives; develop Standard Operating Procedures (SOPs) to support the QMS.
• Training: Maintain keen knowledge of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and appropriate regulatory standards to train and support the operation.

This role requires a non-smoker and is subject to DBS check. We are looking for someone with excellent attention to detail, the ability to recognise areas for improvement and implement change, attaining partner buy in and the desire to be the best at helping to ensure we are fulfilling our commitments to clients and patients.

Due to the nature of testing within this lab we can only consider non-smokers.

Reference ID: ACBSQA0721

Job Types: Full-time, Permanent

Pay: Up to £30,000.00 per year

Benefits:

• Wellness programmes

Schedule:

• Monday to Friday

Work remotely:

• Temporarily due to COVID-19