Senior QA Associate I

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.

Responsibilities

• Carry out job duties by planning, organizing, and leading study-specific inspections and/or internal system/process-based audits with 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; 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 where the individual is expected to demonstrate decision-making ability. However, this is a skills-mastering position with supervisory review and oversight.

Qualifications

• Bachelor’s degree, preferably in life sciences or engineering.
• 4+ years of 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)).

Schedule

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

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan for eligible employees.
• Eligibility to participate in short-term incentive programs.

This job may be eligible for bonuses, commissions, or other forms of compensation at the Company’s discretion.

Pay

The compensation range described is the range of possible base pay the Company believes in good faith it will pay for this role at the time of posting, based on the job grade. Individual compensation paid within this range will depend on many factors, including geographic location, and may vary.