Quality Assurance Auditor I

About the role

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

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
• Audit and inspect support for 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

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
• Displays versatility and accuracy when performing various tasks, some of which may be difficult and/or non-routine
• Ability to comprehend and apply applicable government regulations
• Proficient in the use of computer software applications as needed to effectively conduct QA duties (e.g., Word, Outlook, Excel, SharePoint)

Skills

• 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 comprehend and apply applicable government regulations
• Proficient in the use of computer software applications as needed to effectively conduct QA duties (e.g., Word, Outlook, Excel, SharePoint)

Benefits

The pay range estimated for this position is $26.44 - $36.20 per hour. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. 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.

Pay

The pay range estimated for this position is $26.44 - $36.20 per hour.

Schedule

Not specified