Quality Assurance Auditor

Position Requirements Education and Experience

• B.S. in chemistry or life sciences or Bachelor’s degree or higher in a related field and Two to four years of experience in a GLP or similarly regulated environment preferably with 1 or more years of auditing experience, or Equivalent combination of education and regulatory, quality, compliance and/or industry experience.

• Excellent written and verbal communication and interpersonal skills with ability to work with personnel at all levels of the organization
• Good organizational skills and detail oriented
• A working knowledge and awareness of general laboratory procedures
• Ability to comprehend and apply applicable government regulations
• Displays versatility and accuracy when performing various tasks, some of which may be difficult and/or non-routine
• Ability to work independently and follow written instructions
• Proficient in the use of computer software applications as needed to effectively conduct QA duties (e.g., Word, Outlook, Excel, SharePoint)
• Ability to comprehend and apply applicable government regulations
• Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions
• Experience with quality systems management and enterprise quality management software preferred

• General Ability to read, write, speak and understand oral and written instructions
• Available for occasional business travel

• Requires moderate physical activity including:
  Standing and/or walking for four (4) or more hours per day
• Repetitive movement of hands and fingers
• Reaching and heavy lifting (up to 50lbs)
• Prolonged periods of sitting and computer work
• May require transit between buildings or sites as well as walking over rough terrain

• Work is normally performed in an office or laboratory environment
• May require use of Personal Protection Equipment (PPE) including latex or nitrile gloves, dust mask and/or respirator, safety glasses and PPE, as required
• Work may involve moderate exposure to elements such as dust, fumes, animal dander and/or moderate noise levels
• May involve exposure to hazardous chemicals as well as biohazards
• TB testing required at some sites (negative Mantoux TB test or chest x-ray)

• Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures
• Maintain confidential information
• Interact with clients, other employees, and the community in a professional manner
• Support and participate in company initiatives as directed
• Maintain thorough knowledge of facility SOPs, policies, study protocols, etc.
• Adhere to all safety regulations and procedures
• Provide assistance or support to other Inotiv QA team members as necessary
• Perform other duties as assigned
• Demonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as applicable international regulations
• Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance
• Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods and relevant regulations (audits may include direct observation of study conduct and/or laboratory processes, review of protocols, study data and reports, or review of facility records and SOPs as well as subcontractor contributions)
• Conduct audits on Validations i.e. risk assessments, user requirements, validation summary report against part 11 compliance.
• Prepare an audit report and submit all findings to Study Director/Principal Investigator and management promptly
• Issue accurate quality assurance statements for inclusion in final reports
• Become familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, and QC
• Input and/or update information in the Master Schedule program as required by GLP regulations and SOPs
• Independently conduct process or facility inspections
• Assist with audits and inspections conducted by Sponsors and regulatory agencies, as requested
• Conduct quality training for new hires and other…