Senior GLP Audit Associate - Hybrid

Purpose

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.

• 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 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.

This role is a hybrid role with onsite at our Lake County Headquarters.

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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.

This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short‑term incentive programs.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.