Job Description

Job Title: Associate Quality Assurance Auditor

Department: Quality

Location: Onsite; York, UK

Hours Per Week: 37.5

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

The Associate Quality Assurance Auditor is responsible for the support of regulated GCP & GLP activities including the development, implementation and on-going continuous improvement of the site’s Audit Program.

RESPONSIBILITIES

• Independently performs document audits including but not limited to Master Control documents, Quality Events, etc.

• Manages the receipt and review of necessary documentation for customer initiated audits and mock regulatory inspections and regulatory facility inspections

• Develops Quality metrics, as required

• Serve as a resource for the promotion and compliance with regulations, guidelines, Quality Management System and Standard Operating Procedures within the organization

• Monitors and assesses all required standards, laws and guidelines including any pending changes or new regulations

• Support client, regulatory and sub-contractor audits

• Collaborate with QA Auditors, Sr. QA Auditors, QA Supervisor and QA Manager as needed

• Participate in monthly laboratory Quality Assurance meetings

• Perform other duties as assigned

REQUIRED QUALIFICATIONS

• Bachelor’s Degree OR 3+ Years’ experience in a laboratory, pharmaceutical, medical device or clinical research organization

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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.