Quality Assurance Auditor I at Inotiv

CorporateDemonstrate Inotiv Core ValuesFollow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and proceduresMaintain confidential informationGeneral Interact 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 assignedSpecificConduct 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 promptlyIssue 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 SOPsParticipate in process or facility inspections, as assignedAssist with audits and inspections conducted by Sponsors and regulatory agencies as requestedSupport training of other employees and provide guidance on regulatory topics as requestedPerform other duties as assigned.Position RequirementsEducation and ExperienceB.S. in chemistry or life sciences orB.S./B.A. in related field with 1-3 years pharmaceutical auditing experience or3-5 years of pharmaceutical laboratory experience with 1 year 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)Performance 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 terrain*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.Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over 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.