Quality Assurance Auditor II

Inotiv•Rockville, MD

5d•Onsite

About The Position

The Quality Assurance Auditor II is responsible for ensuring compliance with protocols, Standard Operating Procedures (SOPs), and relevant regulations within a GLP or similarly regulated environment. This role involves conducting audits, preparing reports, and providing training to maintain high standards of quality and regulatory adherence. The position offers opportunities for professional growth within a leading global contract research organization that partners with researchers to advance the development of new medicines and therapies.

Requirements

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

Nice To Haves

Experience with quality systems management and enterprise quality management software preferred

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