Quality Assurance Specialist

Department: Quality

Location: Onsite; York, UK

Hours Per Week: 37.5

Schedule: Monday - Friday 9:00 AM - 5:00 PM

SUMMARY

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

RESPONSIBILITIES

• Serve as a resource for the promotion and compliance with regulations, guidelines, Quality Management System and Standard Operating Procedures within the organization, including training opportunities to staff at an organizational level
• Maintain current awareness of all required standards, laws and guidelines
• Support client, regulatory and sub-contractor audits
• Host/Lead customer initiated audits and mock regulatory inspections and regulatory facility inspections
• Support Sr. QA Auditors, QA Supervisor and QA Manager, as needed
• Responsible for ensuring assigned internal audit & vendor audits are completed as scheduled and reporting associated metrics to Quality Assurance Management
• Participate in monthly laboratory Quality Assurance meetings, assisting the Manager, Quality Assurance, as needed
• Prepare for, carryout, report and follow up of Quality Assurance required audits, including internal, 3rd party and vendor audits
• Manage client audit schedule
• Serve as Quality Assurance contact for assigned customers & functional areas
• Serve as subject matter expert in assigned area
• Manage the compliance and management of programs such as: Internal & External Audits, Vendor Management
• Identify process improvements and initiatives to improve efficiency and effectiveness of assigned program(s)
• Recognize problems related to project objectives and apply sound judgement when addressing the issues
• Review records created under the Quality System, to ensure compliance with defined processes
• Audit documents for compliance with regulations and QMS
• Monitor the compliance of all departments via routine audits to ensure adherence with internal Standard Operating Procedures & external regulations
• Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits
• Manage and support client audits pre and post activities
• Perform other duties as assigned

REQUIRED QUALIFICATIONS

• Bachelor’s Degree & 1 Year experience in a laboratory, pharmaceutical, medical device or clinical research organization OR
• 4+ Years’ experience in a laboratory, pharmaceutical, medical device or clinical research organization

PREFERRED QUALIFICATIONS

• Effective written and oral communication, technical writing and editing skills
• Knowledge of and demonstrated experience in Quality Assurance, GCP, ISO15189, Proficiency Testing, CAP, CLIA, GLP

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.