Senior QA Associate I

About the Role

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. This is an independent quality assurance auditor position with decision-making ability, though it is a skills-mastering role with supervisory review and oversight. The role is hybrid, with onsite work at our Lake County Headquarters.

Responsibilities

• Plan, organize, and lead study-specific inspections and/or internal system/process-based audits.
• Review raw data, protocols, and research reports to ensure quality, integrity, and compliance with 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 during inspections by regulatory agencies.
• Prepare and present project progress reports to update management and keep teams informed.
• Participate on cross-functional project teams.

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 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)).

Benefits

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

Note: Benefits and compensation are subject to Company discretion and may be modified consistent with applicable law.