QA Remediation Specialist

Job Title: QA Remediation SpecialistJob Description

As a QA Remediation Specialist, you will play a critical role in ensuring compliance with FDA regulations and requirements. Your responsibilities will include reviewing and analyzing FDA 483 observations and associated documentation. You will collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs), assist in root cause investigations, and ensure documentation meets regulatory expectations. Additionally, you will draft, revise, and manage SOPs, work instructions, and quality records to align with compliance requirements. Your role will also involve supporting training efforts related to new or revised procedures, monitoring the progress of remediation activities, and tracking CAPA effectiveness. You will prepare and present status updates and reports to management and stakeholders, ensuring all remediation activities are completed within defined timelines and meet FDA expectations.

Responsibilities

• Review and analyze FDA 483 observations and associated documentation.

• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).

• Assist in root cause investigations and ensure documentation meets regulatory expectations.

• Draft, revise, and manage SOPs, work instructions, and quality records to align with compliance requirements.

• Support training efforts related to new or revised procedures.

• Monitor progress of remediation activities and track CAPA effectiveness.

• Prepare and present status updates and reports to management and stakeholders.

• Ensure all remediation activities are completed within the defined timeline and meet FDA expectations.

Essential Skills

• Quality assurance

• FDA compliance

• Remediation

• Experienced in communicating with FDA inspectors to respond to regulatory inquiries

• Experience with FDA 483 observations and contribution to remediation efforts

• Demonstrated experience creating and maintaining quality documentation

Additional Skills & Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field

• Minimum 3-5 years of experience in pharmaceutical quality assurance or compliance

• Proven experience with FDA 483 remediation and GMP regulations

• Strong understanding of CAPA systems, deviation management, and documentation practices

• Excellent communication, organizational, and analytical skills

• Ability to work independently and in a fast-paced, deadline-driven environment

• Experience with FDA audits and inspection readiness

• Familiarity with electronic quality management systems (eQMS)

Work Environment

This position requires you to work onsite full-time. You should be comfortable working with a remote manager and providing weekly updates. You will need to track work completed on a weekly basis and monitor deliverables, while organizing your schedule and working independently.

Job Type & Location

This is a Contract position based out of Lake Villa, IL.

Pay and Benefits

The pay range for this position is $55.00 - $60.00/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 Lake Villa,IL.

Application Deadline

This position is anticipated to close on Nov 29, 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 [email protected] (%[email protected]) for other accommodation options.