Job Title: Quality Assurance SpecialistJob Description The Quality Assurance Specialist plays a pivotal role in managing the Quality Assurance inbox for out-of-specification reviews across multiple labs, including chemistry, calibration, engineering, R&D, formulation, and microbiology. This position serves as the main point of contact between the lab and the Quality Assurance team, ensuring the smooth release of tests and products, while adhering to FDA guidelines. Responsibilities + Manage the Quality Assurance inbox for out-of-specification reviews across various labs. + Act as the main point of contact between the lab and the Quality Assurance team. + Conduct root cause analysis to identify and resolve issues independently. + Perform failure investigations and make recommendations for next steps, collaborating with lab teams and managers. + Assist with Corrective and Preventive Actions (CAPAs), deviations, and investigations. + Support audits and be willing to learn and shadow the process when FDA audits are conducted. + Assist with documentation and file management for the lab and FDA. + Update Standard Operating Procedures (SOPs) and lab procedures as needed. + Provide batch record support when necessary. Essential Skills + Bachelor of Science in Chemistry, Biology, or related field. + 1-3 years of previous experience in investigations, CAPA, deviations, and Quality Assurance. + Strong problem-solving skills and a proactive approach to finding solutions. + Experience in leading Quality Assurance activities. + Ability to ask questions and seek answers from internal partners. Additional Skills & Qualifications + Experience with audits is a plus. + Risk management experience is a plus. + Experience with Medical Device products related to CAPAs, Investigations, Deviations, etc. + 3-6 years of experience in Quality Assurance is ideal. Work Environment This role is primarily remote, with up to 95% of work done remotely, requiring presence within an hour's distance of Chicago. The office environment is above the laboratory, where team meetings with QA/Regulatory Compliance and lab managers occur. The Quality Assurance Group supports various lab departments, including design and verification, R&D, Microbiology, and Chemistry. The position offers opportunities for growth and exposure to FDA audits, with the potential to transition into a leadership role. Job Type & Location This is a Contract to Hire position based out of Mundelein, IL. Pay and Benefits The pay range for this position is $37.00 - $48.00/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 hybrid position in Mundelein,IL. Application Deadline This position is anticipated to close on Feb 14, 2026. 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.