Quality Assurance Technician I

Quality Assurance Unit (QAU) ensures that all Good Laboratory Practice (GLP) studies conducted are performed in compliance with 21 CFR Part 58. QAU is responsible for monitoring study activities to verify adherence to GLP standards and internal procedures. The QA Tech I reports to QA Tech II, and the QAU reports directly to Testing Facility Management., · Review facility records and facility raw data

· Follow up on Study Director or Testing Facility Management responses to observations from QA reports (critical phase inspections, training observations, in-life audits, etc.)

· Perform SOP Audits/Training Observations

· Assist in identifying, documenting, & drafting deviations (facility, SOP, protocol, GLP, etc.)

· Assure that each QA GLP study file contains copies of (but is not limited to) the protocol, and amendments/deviations (if any); also, copies of the GLP Protocol Audit Checklist, GLP Inspection Report, and GLP Report Audit Checklist

· Monitor IBEX Facility Maintenance Schedule (Conduct periodic checks of maintenance and calibration schedules to flag missing entries or upcoming due dates)

· Assist with Annual Facility Audit

· Assist with SOP/appendix revisions and SOP distribution

· Assist in reviewing training records for accuracy and confirm required trainings are current

· Assist admin with 2-person verification for final reports

· Assist with Archiving

· Mentor team members and promote a culture of quality and continuous improvement.

· IBEX Staff Resource

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time.

Do you have experience in Word embeddings?, Do you have a High school diploma or GED?, · High School Diploma

· Basic knowledge of MS Word, Excel and Windows

· Ability to lift at least 25 lbs.

· Able to wear PPE as required

Preferences:

· Background in a GLP environment

· Understanding of the GLPs

· Previous experience in a research setting

· Previous experience with raw data review

Skills:

· Attention to detail

· Ability to operate independently with minimal guidelines

· Communication Proficiency

· Time Management

· Collaboration Skills

· Personal Effectiveness/Credibility

· Flexibility

· Filing

Pulled from the full job description

• Parental leave
• 401(k)
• Health insurance
• 401(k) matching
• Paid time off
• Vision insurance
• Health savings account, * 401(k)
• 401(k) matching
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance