Inotiv is a growing contemporary drug discovery and development company, and they are seeking a Quality Assurance Auditor I. The role involves conducting audits of studies and facilities to ensure compliance with protocols and regulations, while also supporting company initiatives and providing assistance to QA team members as necessary.
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
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
Participate in process or facility inspections, as assigned
Assist with audits and inspections conducted by Sponsors and regulatory agencies as requested
Support training of other employees and provide guidance on regulatory topics as requested
Perform other duties as assigned
Qualification
Required
B.S. in chemistry or life sciences or
B.S./B.A. in related field with 1-3 years pharmaceutical auditing experience or
3-5 years of pharmaceutical laboratory experience with 1 year 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)
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 50 lbs), Prolonged periods of sitting and computer work, May require transit between buildings or sites as well as walking over rough terrain
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)
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
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
Participate in process or facility inspections, as assigned
Assist with audits and inspections conducted by Sponsors and regulatory agencies as requested
Support training of other employees and provide guidance on regulatory topics as requested
Perform other duties as assigned
Preferred
Benefits
Health and dental coverage
Short- and long-term disability
Paid time off
Paid parental leave
401K
Inotiv provides biopharmaceutical analytical, reproductive toxicology, medical device testing, DMPK, consulting and pathological services.
