AbbVie

Senior Auditor, Nonclinical (GLP and SAT)

Employer
AbbVie
Location
Irvine, California
Posted
May 01, 2021
Ref
2104157
Required Education
Bachelors Degree
Position Type
Contract
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn.

This position leads and participates in Nonclinical Quality audits and assessments within R&D Quality Assurance.  The activities include Good Laboratory Practice (GLP) Quality Assurance audits, as well as system/process audits of the Select Agent and Toxins (SAT) program.  The individual will be involved in audit identification, planning, and risk management primarily with GLP and SAT related projects.  Participates in, and may lead, audits of internal quality assurance projects, validations, systems, and/or facilities, as well as audits of external contract vendors to assure AbbVie preclinical trials comply with all applicable regulatory requirements, standards, and applicable AbbVie policies and procedures.  May have a specific special area of responsibility. Interacts with and advises nonclinical partners regarding various elements of project and system quality. 

Responsibilities:

  • Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
  • Plan, organize and conduct preclinical GLP vendor compliance audits, study audits, system audits, process audits, phase audits, and facility audits
  • Plan, organize and conduct SAT system/process compliance audits
  • Review audit responses and CAPAs for adequacy and follows audits to closure
  • Effectively communicate audit results, both orally and in writing
  • Evaluate the potential risk of compliance deficiencies
  • Work with management in the development and provision of meaningful audit metrics and trending reports
  • Support inspection readiness activities and provides support during regulatory authority inspections of AbbVie preclinical processes and GLP studies
  • Review policies and procedures and suggest improvements
  • Supports internal process quality improvements, as assigned
  • Work independently as well as a team member

This position will require travel 25% of the time.


Qualifications

Qualifications

  • Bachelor’s degree in a physical science, life science, pharmacy, engineering or equivalent experience required
  • At least two years of experience as a GLP auditor (e.g. as the Quality Assurance Unit QAU); or 2 years of SAT experience with a focused quality/compliance role
  • Proven understanding of nonclinical processes and systems
  • Knowledge/understanding of the approach and perspectives of regulatory agencies, e.g. 21 CFR Part 58, 42 CFR Part 73
  • Excellent writing and communication skills and attention to detail

The following certifications are desirable:

  • RQAP-GLP
  • ASQ Quality Auditor

Job Grades are determined by the country in which the payroll is based.

Position will be hired based on level of experience. 


Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.