Senior QA Associate I

AbbVie; Illinois; Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, vision insurance

401(k)

Job summary

AbbVie is seeking a Quality Assurance Auditor to join their team in Lake County. This hybrid role requires planning and leading inspections, reviewing data for quality, and guiding others on GLP regulations. Ideal candidates will have a Bachelor's degree in life sciences or engineering and over 4 years of relevant experience.

Joining AbbVie means being part of an innovative company focused on advancing healthcare. Along with a competitive salary, we offer comprehensive benefits, including medical, dental, and a 401(k) plan.

Qualifications

• 4+ years’ experience in toxicology, bioanalytical laboratory, or related fields.
• General understanding of GxP regulatory standards.
• Accreditation by ASQ is desirable.

Responsibilities

• Plan, organize, and lead study-specific inspections.
• Review raw data and research reports for quality assurance.
• Provide guidance on GLP regulations.

Skills

Quality Assurance

Regulatory Affairs

Analytical Chemistry

Toxicology

Education

Bachelor’s degree in life sciences or engineering

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.

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.

Responsibilities

• Carry out 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.

Qualifications

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)).

Compensation and Benefits

• 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.

Equal Opportunity

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.