Quality Assurance Associate

Description

• Establish and maintain a Supplier Quality Management Program for CMOs, CTLs, 3PLs, raw material suppliers, and packaging component suppliers.
• Develop and maintain critical SOPs for supplier management, including supplier qualification, auditing, issue resolution, and change control.
• Author, review, and maintain essential SOPs governing supplier qualification, audits, risk management, supplier monitoring, and supplier-related change control.
• Collaborate with suppliers to address audit findings and ensure timely implementation of corrective and preventive actions (CAPAs).
• Manage supplier-related deviations, non-conformances, and CAPAs, ensuring effective root cause analysis and resolution.
• Ensure supplier quality practices comply with FDA, ICH Q7, USP, and ISO 9001 (as applicable).
• Spearhead the development, negotiation, and maintenance of Quality Agreements with CMOs, CTLs, 3PLs, and material suppliers.
• Support regulatory inspections and internal audits by providing supplier quality documentation as needed.
• Monitor supplier performance through quality metrics, supplier evaluations, and risk assessments.
• Plan, coordinate, and execute supplier audits to assess compliance with cGMP, ICH, and regulatory standards.
• Ensure Quality Agreements align with regulatory requirements and internal quality expectations.
• Develop and maintain a supplier qualification and requalification process to ensure ongoing compliance.

Requirements

• 5+ years of experience in Supplier Quality, Quality Assurance, or Quality Compliance in a pharmaceutical, biotech, or regulated industry.
• Strong analytical, problem-solving, and risk assessment skills.
• Excellent communication and negotiation skills for working with suppliers and cross-functional teams.
• Bachelor’s degree in a scientific discipline (Chemistry, Microbiology, Engineering, or related field).
• Experience managing supplier audits, supplier qualification programs, and quality agreements.
• Experience working with CMOs, contract laboratories, and 3PLs is highly preferred.
• Strong knowledge of cGMP, ICH guidelines, FDA regulations, and quality systems.

Benefits

• Employee Assistance Program
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Transportation benefits
• Medical, dental & vision
• Health Spending Account (HSA)
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Mount Prospect,IL. Application Deadline This position is anticipated to close on Dec 11, 2025.
• Short and long-term disability
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance