Job Title: Quality Assurance Auditor
Department: Quality
Location: Onsite
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.Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.