Quality Remediation Specialist

Job Title:

QA Remediation Specialist  Job 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 $40.00 - $65.00/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 Lake Villa,IL.

Application Deadline This position is anticipated to close on May 1, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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 Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.