Hiring: Quality Assurance Specialist (CDMO) Company: Hays Location: Greater Chicago Area Job Posted Time: 2026-09-11 11:53:35 Target Skills & Keywords : Microsoft Excel, Microsoft Office, Quality Assurance, Root Cause Analysis, Stakeholder Management About the job Experience: •3 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry. Required Skills: •Assist in the maintenance and tracking of all Quality related documentation including, but not limited to: SOPs, Protocols, Investigations, CAPAs, Planned Deviations, Change Controls, etc. •Maintains all investigation and CAPA related documentation as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs. •Assists in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the company’s Quality System. •Tracks and trends appropriate metrics for open Investigations, CAPAs, planned deviations, etc. •Reports monthly metrics pertaining to investigations and CAPAs to Quality department management and other appropriate company personnel. •Actively participate in the review and approval of batch record documentation to support quality release of drug product in a timely manner. •Perform risk assessment to determine safety and efficacy of products. •Assist in change control management program and document archival. Qualifications: •Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field. Compensation: •$70,000 - $90,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!