Quality Assurance Auditor I

Inotiv•Gaithersburg, MD

5d•Onsite

About The Position

The Quality Assurance Auditor I will interact with clients, other employees, and the community in a professional manner. This role supports and participates in company initiatives as directed, maintains thorough knowledge of facility SOPs, policies, and study protocols, and adheres to all safety regulations and procedures. The position also provides assistance or support to other Inotiv QA team members as necessary. The role involves conducting audits of designated studies and facilities to assess compliance with protocols, SOPs, methods, and relevant regulations. This includes direct observation of study conduct and/or laboratory processes, review of protocols, study data and reports, facility records, SOPs, and subcontractor contributions. The auditor will prepare and submit audit reports promptly, issue quality assurance statements for final reports, and become familiar with electronic data collection systems. Responsibilities also include inputting and/or updating information in the Master Schedule program, participating in process or facility inspections, assisting with Sponsor and regulatory agency audits, and supporting training of other employees.

Requirements

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
TB testing required at some sites (negative Mantoux TB test or chest x-ray)

Responsibilities

Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods and relevant regulations
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
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
Demonstrate Inotiv Core Values
Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures
Maintain confidential information