QA Auditor

Inotiv

Gaithersburg, Maryland, United States

Gaithersburg, Maryland, United States

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Über

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 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.
Base salary for this position ranges from $69,700 to $85,000 and will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. 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 Base salary for this position ranges from $69,700 to $85,000 and will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
*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.

Gaithersburg, Maryland, United States

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English

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