QA Auditor

QA Auditor page is loaded## QA Auditor remote type:
On-site locations:
Gaithersburg, MDtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
JR101069
* Demonstrate Inotiv Core Values
* Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures
* Maintain confidential information
* General
* * 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
* Specific
* * 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
* Perform other duties as assigned.

Base salary for this position ranges from $69,700 to $85,000 and will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
* Education and Experience
** B.S. in chemistry or life sciences or Bachelor’s degree or higher in a related field and
* 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.

* Skills and Abilities

** 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 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
*** Performance Requirements
**** General
* * Ability to read, write, speak and understand oral and written instructions
* Available for occasional business travel
* Physical Activity
** Requires moderate physical activity including:  + Standing and/or walking for four (4) or more hours per day  + Repetitive movement of hands and…