Quality Assurance Auditor I - DSA

Company: Envigo RMS
Location: Maryland Heights
Posted on: January 27, 2023

Job Description:

Overview:
Assist with duties and activities to support regulated non-clinical (GLP) and clinical (GCP) studies through audits and inspections of study and facility related activities.

Responsibilities:
Conduct audits/inspections of study activities and provide Study Directors, Principal Investigators, Lead QA, and Site and Facility Management (as applicable) with timely reports including responses and corrective actions takenConduct facility inspections to ensure compliance and appropriateness of processesConduct software validation inspections/audits as necessaryProvide miscellaneous, internal inspection/auditing services as requested for non-regulated -business areasAssist in hosting agency inspections and client Quality Assurance reviewsAssist in training of Inotiv employees as necessaryInteract with clients, other employees, and the community in a professional mannerSupport and participate in company initiatives as directedMaintain thorough knowledge of facility SOPs, policies, study protocols, etc.Adhere to all safety regulations and proceduresProvide assistance or support to other Inotiv site QA as necessaryFollow all SOPs and other applicable laboratory or company policies and proceduresMaintain confidential informationPerform other duties as assignedSkills and AbilitiesGood organizational skills and detail orientedExcellent communication and interpersonal skills with ability to work with personnel at all levels of the organizationDisplays versatility and accuracy when performing various tasks, some of which may be difficult and/or non-routine.A working knowledge and awareness of general laboratory procedures.Ability to work independently.Proficient in the use of computer software applications as needed to effectively conduct QA reviews (e.g., Word, Outlook, Excel)Ability to read/write English and understand applicable materialsAvailable for occasional business travelDemonstrate Inotiv Core Values

Qualifications:
Bachelor's degree or equivalent combination of applicable regulatory, quality, and/or compliance-related experience with Management approvalThree years or more of auditing experience in a GLP or similarly regulated environment, or -Five years or more of qualified industry experience with Management approval

Keywords: Envigo RMS, Springfield , Quality Assurance Auditor I - DSA, Accounting, Auditing , Maryland Heights, Illinois