Senior Quality Assurance Auditor

Senior Quality Assurance Auditor page is loaded

Senior Quality Assurance Auditor

Apply locations ACM – York Building 23 ACM – York Building 36 time type Full time posted on Posted 23 Days Ago job requisition id REQ_211027

Job Title: Senior Quality Assurance Auditor

Department: Quality

Location: Hybrid

Hours Per Week: 37.5

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

SUMMARY

As a Senior Quality Assurance Auditor within the Quality team, the Senior 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 Senior 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
• Manage customer initiated audits and mock regulatory inspections and regulatory facility inspections
• Support 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 & 3 Year’s experience in a laboratory, pharmaceutical, medical device or clinical research organization
• OR 6+ 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/Affirmative Action Employer.
Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.

About Us

At ACM Global Laboratories, we understand that every project we work on, every task we complete impacts patients and their families. Our dedication to being purposefully patient-driven is reflected in the high-quality work provided by our teams every day around the globe.

#J-18808-Ljbffr