Quality Assurance Auditor I

Job Title

Position Requirements

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)

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 fingers

Reaching and heavy lifting (up to 50lbs)

Prolonged periods of sitting and computer work

May require transit between buildings or sites as well as walking over rough terrain

Working Conditions

Work is normally performed in an office or laboratory environment

May require use of Personal Protection Equipment (PPE) including latex or nitrile gloves, dust mask and/or respirator, safety glasses and PPE, as required

Work may involve moderate exposure to elements such as dust, fumes, animal dander and/or moderate noise levels

May involve exposure to hazardous chemicals as well as biohazards

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

Responsibilities and Duties

Corporate

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)

Conduct audits on Validations i.e. risk assessments, user requirements, validation summary report against part 11 compliance.

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.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.