Pace Analytical

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Corporate Internal Quality Auditor

Corporate Internal Quality Auditor

ID 
2017-1808
# of Openings 
1
Job Locations 
US-MN-Minneapolis
Category 
Science

More information about this job

Overview

Performs quality auditing activities for Pace Analytical’s Environmental Division to ensure compliance of operations with corporate policies, Standard Operating Procedures (SOPs), industry standards, and applicable regulations.  This includes conducting a variety of audit activities which may include, but not be limited to, facility audits, due diligence audits, and preparation for regulatory audits. 

Provides consultation and mentoring for the organization on current Good Laboratory Practices (cGLP) by ensuring quality activities are performed and documented in compliance with SOPs, company guidelines, and application regulations. Additionally strives to strengthen the quality of our operations through collaboration with operations via the management team and local QMs.  Provides ongoing consultation and communication with Pace Analytical Services Environmental staff for interpretation and implementation of regulations.

Please note: This employee does not need to reside in Minnesota for this role.

Responsibilities

  • Plans, coordinates, manages, supports and/or leads audits according to the Pace Analytical Environmental audit plan, Quality Assurance Program, strategy and priorities
  • Creates and updates audit checklists as requirements change and ensures audits are completed according to checklist requirements
  • Applies a risk-based audit approach for the identification of audit targets with the objective to optimize value, time and resources, while minimizing business risks
  • Performs quality assessments such as quality due diligence audits
  • Conducts routine audits of Pace Analytical Environmental facilities, directed/for cause audits of focused specialized areas, mock audits or inspection readiness (as part of the regulatory inspection preparation for pre-submission/pre-approval/post-approval inspections) according to requirements
  • Prepares and issues quality assessments and/or audit observation reports; assesses adequacy of the laboratory’s responses to audit observations/findings; approval and follow-up of Corrective Action and Preventive Action (CAPA) plan; and distribution of approved final audit reports
  • Ensures appropriate notification to management in case of critical observation/finding, significant quality deviations, and supports immediate follow-up measures according to Pace Analytical’s Environmental Quality System Program
  • Acts as Subject Matter Expert (SME) in areas of expertise by providing sound guidance to Pace Analytical employees, customers, business partners and management, where appropriate
  • Supports in preparation and/or during facilities regulatory authority inspections to ensure the facility is prepared and supported
  • Ensures proper management, follow-up, and closure of audits to support the monthly reporting of key quality indicators associated with the audits, tracking, and completion of CAPAs
  • Supports the Corporate Environmental Quality Manager in developing, implementing and maintaining an effective Quality Management System (QMS) in accordance with ISO 9001:2008 as well as a Quality Manual to ensure compliance in all QMS elements
  • Communicates and liaises with others to drive quality mindset
  • Promotes cooperation and teamwork among staff
  • Follows Pace policies and Standard Operating Procedures (SOPs)
  • Other duties as assigned

Qualifications

  • BA/BS in Science or related field
  • Minimum of 5 years of environmental analytical testing experience and at least 5 years of Quality Assurance auditing experience
  • Extensive knowledge of current Good Lab Practices (cGLP) and Mastery of environmental analytical testing

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