Quality Assurance Auditor I

Employer
Inotiv
Location
Gaithersburg, MD
Posted
Dec 04, 2021
Ref
1354
Required Education
Bachelors Degree
Position Type
Full time

Job Title:

Quality Assurance Auditor I

Qualifications:

BS/BA in biological sciences or related field with 2 years of GLP auditing experience.  Excellent written and verbal communication skills.  Excellent time management skills. 

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.              
  • 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.