Job Description

Quality Assurance Associate

We are seeking a dedicated Quality Assurance Associate to join our team. This role involves overseeing supplier quality management programs, auditing compliance, and developing quality agreements to ensure the highest standards in our manufacturing processes.

Responsibilities:

• 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.
• Monitor supplier performance through quality metrics, supplier evaluations, and risk assessments.
• Develop and maintain a supplier qualification and requalification process to ensure ongoing compliance.
• Plan, coordinate, and execute supplier audits to assess compliance with cGMP, ICH, and regulatory standards.
• Collaborate with suppliers to address audit findings and ensure timely implementation of corrective and preventive actions (CAPAs).
• Spearhead the development, negotiation, and maintenance of Quality Agreements with CMOs, CTLs, 3PLs, and material suppliers.
• Ensure Quality Agreements align with regulatory requirements and internal quality expectations.
• 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).
• Support regulatory inspections and internal audits by providing supplier quality documentation as needed.
• Author, review, and maintain essential SOPs governing supplier qualification, audits, risk management, supplier monitoring, and supplier-related change control.

Qualifications:

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

Job Type & Location:

This is a Contract to Hire position based out of Arlington Heights, IL.

Pay and Benefits:

The pay range for this position is $30.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in Arlington Heights, IL.

Application Deadline:

This position is anticipated to close on Jan 19, 2026.

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