Senior QA Associate I

AbbVie•North Chicago, IL

8d•$84,500 - $162,000•Hybrid

About The Position

Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, auditing and coordination of projects to maintain and improve the quality of work-related processes.

Requirements

Bachelor’s degree, preferably in life sciences or engineering.
4+ years’ experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance and/or Regulatory Affairs.
General understanding of GxP regulatory standards.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Nice To Haves

Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA)

Responsibilities

Carryout job duties, by planning, organizing, and leading study-specific inspections and/or internal system/process-based audits. Requires some supervisory oversight.
Review raw data, protocols and research reports to assure the quality and integrity of the results as well as compliance to protocols, policies, procedures, and applicable governmental regulations; and be able to evaluate the potential risk of compliance deficiencies.
Provide guidance and training on GLP regulations and guidelines to Associate GLP auditors and functional area personnel.
Assist the Inspection Management group on inspections by regulatory agencies.
Prepare and present project progress reports to update management and keep the team(s) informed.
Participate on cross-functional project teams.
This is an independent quality assurance auditor position. The individual is expected to demonstrate decision-making ability. However, this is a skills-mastering position with supervisory review and oversight.