Senior Quality Assurance Specialist

HOW WE CARE FOR YOU:

At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients lives.

• Auto Enrolment Pension
• Comprehensive Benefits Package
• Career Advancement Opportunities including Apprenticeships
• Comprehensive Career Pathways

SUMMARY

As a Senior Quality Assurance Specialist within the Quality team, the Senior Quality Assurance Specialist promotes a supports a culture of audit readiness within ACM Global Laboratories. Responsible for overseeing GCP & GLP activities including the development, implementation and on-going continuous improvement of the site s Audit program within the BioA department. In addition, the Senior Quality Assurance Specialist will interface with the business and functional leaders of the regulated operational areas to promote and support compliance. This position also supports the generation of Key Quality Performance Indicators for the company s Quality Systems.

ACM Global Laboratories is a growing international organization that provides continued opportunities for internal advancement. At ACM you will be part of a team that is focused on improving people s lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding field of advanced laboratory science. Your voice is heard, and with that, you have an ability to make an impact on the organization and influence your professional growth

LOCATION: York

DEPARTMENT:Quality Assurance

SCHEDULE: Monday - Friday

ATTRIBUTES

• Bachelor s degree preferred & 3 years of experience in a laboratory, pharmaceutical, medical device, or clinical research organization OR 6 years of experience in a laboratory, pharmaceutical, medical device, or clinical research organization.
• Knowledge of and demonstrated experience in GCP, ISO15189, NEQAS, CAP, CLIA strongly preferred.
• Certified Quality Auditor preferred.

RESPONSIBILITIES

• Quality Assurance. Ensure the Quality System/personnel is efficient for the business while maintaining compliance (Quality Issues, Change Controls, CAPAs. Lead the development and implementation of Quality Improvement projects. Develop, implement and maintain auditing strategies, to ensure continued compliance with the appropriate current regulations and guidelines. Perform the independent monitoring of all study types conducted within BioA as required by regulation and SOP. Conduct all types of Quality Assurance required audits including process, facility, SOP, CSV and study audits as required. Review and maintain BioA Central Events log so that the corrective and preventative actions (CAPA) that have been proposed by management are actioned and completed in a timely manner Act as Deputy Archivist and therefore responsible for the maintenance of the archive and its contents in compliance with the appropriate regulations. Aid in introducing systems to comply with any revised GLP, GCP, EMA, FDA and OECD guidelines or regulations as they are introduced. Provide support/host with customer-initiated audits, mock regulatory inspections and regulatory facility inspections. Participate in review of root cause analysis, corrective action & preventive action plans for internal, 3rd party & vendor audits
• Process Improvement. Lead develop/improve, implement and maintain any new/modified quality systems that management deem necessary to maintain GLP and GCP compliance. Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits
• Training and Mentoring of Quality Assurance personnel within BioA. Training and Mentoring of Quality Assurance personnel within BioA