Quality Assurance Auditor I at Inotiv in RTP NC - Keystone (200)

Quality Assurance Auditor I

Location: RTP NC - Keystone (200) · On-site

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.

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
• 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

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)
• 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.

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.

At Inotiv, our work helps advance the development of new medicines and therapies that can improve people's lives. As a leading global contract research organization (CRO), we partner with researchers to tackle complex scientific challenges, drive innovation, and help build a healthier, safer world. Bringing together scientists, researchers, technical experts, and business professionals, we provide the expertise and collaboration needed to move research forward. Our people make this work possible, and we value the knowledge, ideas, and contributions each person brings to the team. Whether you are starting your career or bringing years of experience, Inotiv offers opportunities to learn, grow, and play a meaningful role in advancing treatments for patients around the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.