Quality Assurance Associate

Job Title: Quality Assurance Associate

Job Description

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• Experience working with CMOs, contract laboratories, and 3PLs is highly preferred.

Work Environment

The Quality Assurance team operates within a pharmaceutical/antiseptic solutions manufacturing environment. The company follows FDA and GMP guidelines. The role is based in a brand-new office with individual cubicles. The work schedule follows the first shift, typically from 8 am to 4 pm, with some variability. The company is rapidly growing, with plans to expand further into generic drug and European markets.

Job Type & Location

This is a Contract to Hire position based out of Mount Prospect, 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 Mount Prospect,IL.

Application Deadline

This position is anticipated to close on Dec 12, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $30 - $35