Quality Assurance Auditor I

INTEGRATED LABORATORY SYSTEMS LLC; Durham (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Inotiv in Durham, NC is seeking a QA Auditor to support GLP compliance across designated studies and facilities. You will conduct audits, review study protocols and data, and prepare formal audit reports for Study Director and management.

The role requires 2–4 years in GLP or regulated environments, strong regulatory knowledge, and excellent communication. Work is performed in an office/lab setting with opportunities for growth in QA leadership.

Qualifications

• B.S. in chemistry or life sciences or related field; 2-4 years in a GLP-enabled environment.
• One or more years of auditing experience in a regulatory/quality setting.
• Excellent written and verbal communication; ability to interact with all levels of the organization.
• Strong organizational skills and attention to detail.
• Proficient with Word, Outlook, Excel, SharePoint.

Responsibilities

• Conduct audits of designated studies and facilities to assess protocol compliance.
• Prepare audit reports and promptly submit findings to Study Director/PI and management.
• Stay current on FDA/EPA GLPs and applicable regulations.
• Perform QA duties and assist in training for new hires.
• Assist with subcontractor and vendor evaluations.

Skills

QA auditing

GLP/regulatory

Regulatory compliance

Analytical thinking

Communication skills

SOPs

Independent work

Problem solving

Word/Outlook/Excel/SharePoint

Education

B.S. in chemistry or life sciences

Tools

Word

Outlook

Excel

SharePoint

Job description

Position RequirementsEducation and ExperienceB.S. in chemistry or life sciences or Bachelor’s degree or higher in a related field andTwo to four years of experience in a GLP or similarly regulated environment preferably with 1 or more years of auditing experience, orEquivalent combination of education and regulatory, quality, compliance and/or industry experience.Skills and AbilitiesExcellent written and verbal communication and interpersonal skills with ability to work with personnel at all levels of the organizationGood organizational skills and detail orientedA working knowledge and awareness of general laboratory proceduresAbility to comprehend and apply applicable government regulationsDisplays versatility and accuracy when performing various tasks, some of which may be difficult and/or non-routineAbility to work independently and follow written instructionsProficient 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 regulationsAnalytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutionsExperience with quality systems management and enterprise quality management software preferredPerformance RequirementsGeneralAbility to read, write, speak and understand oral and written instructionsAvailable for occasional business travelPhysical ActivityRequires moderate physical activity including:Standing and/or walking for four (4) or more hours per dayRepetitive movement of hands and fingersReaching and heavy lifting (up to 50lbs)Prolonged periods of sitting and computer workMay require transit between buildings or sites as well as walking over rough terrainWorking ConditionsWork is normally performed in an office or laboratory environmentMay require use of Personal Protection Equipment (PPE) including latex or nitrile gloves, dust mask and/or respirator, safety glasses and PPE, as requiredWork may involve moderate exposure to elements such as dust, fumes, animal dander and/or moderate noise levelsMay involve exposure to hazardous chemicals as well as biohazardsTB testing required at some sites (negative Mantoux TB test or chest x-ray)Responsibilities and DutiesCorporateDemonstrate Inotiv Core ValuesFollow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and proceduresMaintain confidential informationGeneralInteract with clients, other employees, and the community in a professional mannerSupport and participate in company initiatives as directedMaintain thorough knowledge of facility SOPs, policies, study protocols, etc.Adhere to all safety regulations and proceduresProvide assistance or support to other Inotiv QA team members as necessaryPerform other duties as assignedSpecificDemonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as applicable international regulationsKeep abreast of new rules, guidance and industry standards in order to improve laboratory complianceConduct 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 promptlyIssue accurate quality assurance statements for inclusion in final reportsBecome familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, and QCInput and/or update information in the Master Schedule program as required by GLP regulations and SOPsIndependently conduct process or facility inspectionsAssist with audits and inspections conducted by Sponsors and regulatory agencies, as requestedConduct quality training for new hires and other employees, as assigned.Participate in or lead subcontractor and/or vendor evaluationsServe as a resource to represent the QA team on regulatory topics (e.g, at study initiation meetings), as requestedParticipate in departmental business, process or general regulatory projects, as assignedPerform 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.