Quality Assurance Auditor I

Position Requirements

Bachelor’s degree or higher in a related field such as chemistry or life sciences, or two to four years of experience in a GLP or similarly regulated environment, preferably with one or more years of auditing experience.

Skills And Abilities

• Excellent written and verbal communication and interpersonal skills
• Good organizational skills and detail oriented
• A working knowledge and awareness of general laboratory procedures
• Ability to comprehend and apply applicable government regulations
• Versatile and accurate when performing various tasks
• Ability to work independently and follow written instructions
• Proficient in the use of computer software applications
• 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

Performance Requirements

• General Ability to read, write, speak and understand oral and written instructions
• Available for occasional business travel
• Physical Activity: Standing and/or walking for four (4) or more hours per day, repetitive movement of hands and fingers, reaching, heavy lifting (up to 50lbs), prolonged periods of sitting and computer work, transit between buildings or sites as well as walking over rough terrain
• Working Conditions: Moderate exposure to elements such as dust, fumes, animal dander and/or moderate noise levels, exposure to hazardous chemicals and biohazards, TB testing required at some sites (negative Mantoux TB test or chest x-ray)

Responsibilities And Duties

• Corporate: Demonstrate Inotiv Core Values, 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
• Specific: 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 employees, as assigned, Participate in or lead subcontractor and/or vendor evaluations, Serve as a resource to represent the QA team on regulatory topics (e.g, at study initiation meetings), as requested, Participate in departmental business, process or general regulatory projects, as assigned, Perform other duties as assigned

Benefits

• Health and dental coverage
• Short- and long-term disability
• Paid time off
• Paid parental leave
• 401K