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Quality Assurance Auditor

Envigo, an Inotiv Company
Gaithersburg, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

COMPANY OVERVIEW

Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity.  Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.  There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen.

Join us in embracing research and science to impact the health and well-being of people all over the world.

Position Responsibilities:

  • Perform protocol, critical phase, raw data, and report audits for compliance with GLPs, SOPs, and protocol.  Report all findings from the audits and inspections to Study Directors, Principal Investigators, Test Site Management, Test Facility Management and Operational Management and scientific personnel.
  • Inspect in-life phases and facilities as required for compliance with GLPs and SOPs and observe technical and professional staff for adherence to health and safety, SOP, and GLP standards.
  • Maintain properly indexed quality assurance records, including study-specific files, inspection/audit status reports, protocols and amendments, internal facility inspection reports, audit logs, and other general QA records.   Assure all QA records are up-to-date and accurate and compile the appropriate records for study-specific archiving.
  • Input/update information into the Master Schedule program as required by GLP regulations.
  • Participate in or conduct subcontractor, vendor, and internal facility inspections for compliance with GLPs and SOPs.
  • Become familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, QC, etc.
  • May participate in quality assurance inspections from existing or potential clients and regulatory agencies, e.g. FDA, EPA.
  • May participate in equipment and software validation efforts. 
  • Attend pre-initiation, pre-planning, or operational team meetings. 
  • Issue quality assurance statements for inclusion in final reports.
  • Maintain and coordinate the archiving of QA study files.
  • Assist or perform other job duties as assigned.

Professional Responsibilities:

  • Attend continuing education courses or webinars, as appropriate.
  • Maintain membership in the Society of Quality Assurance.

Corporate Responsibilities:

  • Adherence to laboratory health and safety procedures.
  • Adherence to Standard Operating Procedures (SOPs).
  • Adherence to applicable company policies and guidelines.
  • Adherence to federal and/or local regulations, as applicable. 

Qualifications:

  • BS/BA in biological science or related field with 2 years of GLP auditing experience.
  • Excellent written and verbal communication skills.
  • Excellent time management.
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Company Description
Where insights lead to answers.
Inotiv careers are dynamic, meaningful and have an extraordinary impact on people's lives.
Join our team and help drive innovations forward.
analyze. answer. advance.

Inotiv is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Envigo, an Inotiv Company

Address

Gaithersburg, MD
USA

Industry

Technology