Job Title: Quality Assurance Associate

Job Description

We are seeking a dedicated and experienced Quality Assurance Associate to join our dynamic team. In this role, you will be responsible for managing and overseeing our Supplier Quality Management Program, ensuring compliance with regulatory requirements, and maintaining high-quality standards across our supply chain.

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 (on-site, virtual, and desktop reviews) to assess compliance with cGMP, ICH, and regulatory guidelines.
• Document audit activities, including scheduling, performing, and documenting audit findings in supplier audit reports.
• 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.
• Work with Legal, Regulatory, and Supply Chain teams to maintain up-to-date agreements.
• Manage supplier-related deviations, non-conformances, and CAPAs.
• Ensure effective root cause analysis (RCA) and resolution of supplier issues.
• Review and assess supplier-initiated change controls for impact on product quality and compliance.
• Ensure supplier quality practices comply with FDA, ICH Q7, USP, and ISO 9001 (as applicable).
• Maintain awareness of industry best practices and evolving regulatory requirements.
• 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.
• Ensure SOPs align with current regulatory expectations and industry best practices.
• Train internal stakeholders on supplier management procedures to ensure consistent application.

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

You will be part of the Quality Assurance team in our office at a Pharma/antiseptic solutions manufacturer. The company follows FDA and GMP guidelines and operates primarily on the 1st shift from 8 am to 4 pm (times may vary). You will have your own brand new cubicle in a newly constructed office. The company is growing rapidly, with increased sales of current products and new acquisitions. We recently expanded our facilities, including the Lake Villa site and a new building across the street from the Mount Prospect original site.

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 Feb 28, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $30 - $35