Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist will manage the Quality Assurance inbox for out-of-specification reviews across various labs, including chemistry, calibration, engineering, R&D, formulation, and microbiology. This role acts as the main point of contact between the lab and the Quality Assurance team, facilitating the release of tests and products.

Responsibilities

• Manage Quality Assurance inbox and facilitate communication between labs and the QA team.
• Conduct failure investigations and provide recommendations for next steps in collaboration with lab teams and managers.
• Assist with Corrective and Preventive Actions (CAPAs), deviations, and investigations.
• Support audit processes, including assisting during FDA audits.
• Assist with documentation and file retrieval for labs and FDA.
• Update Standard Operating Procedures (SOPs) and lab procedures as needed.
• Provide batch record support when required.

Essential Skills

• Bachelor of Science in Chemistry, Biology, or related field.
• 1-3 years of experience in investigations, CAPA, deviations, and Quality Assurance.
• Experience leading activities related to quality assurance and problem-solving.
• Proficiency in Microsoft Excel and quality management systems.
• Strong documentation review skills.

Additional Skills & Qualifications

• Experience with audits is a plus.
• Medical device product experience is ideal.
• 3-6 years of experience in Quality Assurance is preferred.
• Critical thinking and problem-solving skills are essential.
• Ability to handle a variety of personalities and maintain a customer service mindset.

Work Environment

The role supports the Quality Assurance Group at a laboratory site, interacting with design and verification, R&D, microbiology, and chemistry groups. The position is 95% remote, requiring proximity within one hour of the Chicago area. Office hours are 9am-5pm, with occasional in-office days for team meetings. The work environment includes remote work with occasional office attendance above the laboratory.

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 May 17, 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.