Inotiv

drug discovery and development

QualityAssuranceAuditor

$0–0k Gaithersburg, Maryland, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Quality Assurance Auditor at Inotiv. Skills: Quality Assurance, Auditing, Compliance, Pharmaceutical. Interact with clients. Support company initiatives”

What You'll Achieve.

assess compliance with protocols, SOPs, methods and relevant regulations; submit all findings to Study Director/Principal Investigator and management promptly; Issue accurate quality assurance statements for inclusion in final reports.

Industry & Context.

drug discovery and development
Eligibility Requirements

Available for occasional business travel, Standing and/or walking for four (4) or more hours per day, Repetitive movement of hands and fingers, Reaching and heavy lifting (up to 501bls), Prolonged periods of sitting and computer work, May require transit between buildings or sites, walking over rough terrain, May require use of Personal Protection Equipment (PPE), TB testing required at some sites

What They're Looking For.

Must Have

B. S. in chemistry or life sciences, B. S. /B. A. in related field with 1-3 years pharmaceutical auditing experience, 3-5 years of pharmaceutical laboratory experience with 1 year of auditing experience, Equivalent combination of education and regulatory, quality, compliance and/or industry experience, Ability to comprehend and apply applicable government regulations, Ability to work independently and follow written instructions

Nice to Have

Familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, and QC.

What You'll Do.

Interact with clients

Support company initiatives

Maintain knowledge of facility SOPs

Adhere to safety regulations

Provide assistance to QA team members

Conduct audits of designated studies

Assess compliance with protocols

Prepare an audit report

How You'll Work.

Team & Collaboration

Interact with clients, other employees, and the community in a professional manner; Provide assistance or support to other Inotiv QA team members as necessary; Support training of other employees; provide guidance on regulatory topics

Communication Scope

Excellent written and verbal communication; interpersonal skills

Full Job Description

•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 **Quality Assurance Auditor I** **Position Requirements** _Education and Experience_ * 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. _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) **_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 501bls) * 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 l

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