Quality Assurance Auditor III

Position Requirements

Education and Experience

• B.S. in chemistry or life sciences or Bachelor’s degree or higher in a related field and
• Three to five years of experience in a GLP preferably with 1-3 or more years of auditing experience, or
• Equivalent combination of education and regulatory, quality, compliance and/or industry experience.
• RQAP-GLP certification preferred.

Skills and Abilities

• 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
• 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
• Advanced knowledge of regulatory framework and interpretation and application of regulations
• Understands business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution
• 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
• Lean/Six Sigma certification or other process improvement-related experience preferred

Performance Requirements

General

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

Physical Activity

• 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

Working Conditions

• 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)

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

General

• 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)
• 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
• Demonstrate solid knowledge of 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
• Actively participate in managing quality program to ensure compliance with regulatory requirements and serve as a resource for staff on regulatory topics.