Quality Assurance Auditor I

Inotiv•Gaithersburg, MD

4d•$26 - $36•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 auditor will also provide assistance or support to other Inotiv QA team members as necessary. This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level. Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world. Salary will be commensurate with experience and responsibilities. Inotiv is a leading contract research organization (CRO), Inotiv supports discovery and nonclinical development through investigational new drug (IND) and beyond. By leveraging our deep expertise and scientific capabilities, we help you increase efficiency, improve data, and reduce the cost of taking new drugs to market. By providing critical research models and related services, we help researchers realize the full potential of their R&D projects, all while working together to build a healthier and safer world. We hope you consider our opportunities and a future with Inotiv!

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

Responsibilities

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
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