Inotiv · 19 hours ago
QA Auditor
Gaithersburg, MD
Full-time
Onsite
Entry, Mid Level
$70K/yr - $85K/yr
2+ years expInotiv is a growing contemporary drug discovery and development company that focuses on delivering world-class drug discovery and development solutions. The QA Auditor role involves conducting audits to ensure compliance with protocols and regulations, maintaining knowledge of SOPs, and providing quality training to new hires and employees.
BiopharmaLife ScienceMedical DevicePharmaceutical
Responsibilities
Demonstrate Inotiv Core Values
Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures
Maintain confidential information
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
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
Qualification
Required
B.S. in chemistry or life sciences or Bachelor's degree or higher in a related field
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
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)
Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions
Ability to read, write, speak and understand oral and written instructions
Available for occasional business travel
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
Preferred
Experience with quality systems management and enterprise quality management software preferred
Benefits
Health and dental coverage
Short- and long-term disability
Paid time off
Paid parental leave
401K
And more
Company
Inotiv
Inotiv provides biopharmaceutical analytical, reproductive toxicology, medical device testing, DMPK, consulting and pathological services.
1001-5000 employees
H1B Sponsorship
Inotiv has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (2)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$27.64MKey Investors
Indiana Economic Development Corporation
2024-12-18Post Ipo Equity· $27.6M
2022-06-20Grant· $0.04M
1997-11-28IPO
Leadership Team
Greg Beattie
Chief Operating Officer
Recent News
2025-12-13
Company data provided by crunchbase