Quality Assurance Auditor III

·       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

·       Demonstrate solid knowledge of 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

·       Actively participate in managing quality program to ensure compliance with regulatory requirements and serve as a resource for staff on regulatory topics.

·       Support and/or participate in quality assurance inspections from existing or potential clients and regulatory agencies. Assist with managing responses including provision of corrective and preventive actions as assigned. 

·       Conduct site- specific and corporate quality training for new hires and other employees, as assigned.

·       Champion the development of standard Quality policies, procedures, job aids and training documents.

·       Support investigation and CAPA activities to ensure elimination or mitigation of quality issues and risks.  Apply problem solving methodology including root cause analysis to situations where data suggest process is not operating effectively or variability exceeds expectations.

·       Participate in or lead subcontractor and/or vendor evaluations

·       Participate in equipment and software validation efforts.

·       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.

·       B.S. in chemistry or life sciences or Bachelor’s degree or higher in a related field and

·       Three to five years of experience in a GLP preferably with 1-3 or more years of auditing experience, or

·       Equivalent combination of education and regulatory, quality, compliance and/or industry experience.

·       RQAP-GLP certification preferred.

·       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

·       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

·       Advanced knowledge of regulatory framework and interpretation and application of regulations

·       Understands business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution

·       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

·       Lean/Six Sigma certification or other process improvement-related experience preferred

·       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

·       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)