Senior GLP Audit Associate I - Hybrid

Responsibilities

• List up to 10 responsibilities of the job including information regarding scope and accountability.
• 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.
• 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:
• 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.
• AbbVie 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.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Benefits

Additional Information

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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Abbvie? Share your experience