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QA Remediation Specialist
QA Remediation SpecialistActalent • Lake Villa, IL, US
QA Remediation Specialist

QA Remediation Specialist

Actalent • Lake Villa, IL, US
1 day ago
Job type
  • Full-time
Job description

QA Remediation Specialist

Join our team as a QA Remediation Specialist, where you will play a critical role in 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. Your expertise will drive the drafting, revising, and management of SOPs, work instructions, and quality records to align with compliance requirements. You will support training efforts related to new or revised procedures and monitor the progress of remediation activities, tracking CAPA effectiveness. Additionally, you will prepare and present status updates and reports to management and stakeholders, ensuring all remediation activities are completed within the defined timeline 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 and FDA compliance expertise.
  • Experience in communicating with FDA inspectors to respond to regulatory inquiries.
  • Ability to walk through experience with FDA 483 observations and how they contributed to remediation efforts.
  • Demonstrated experience in creating and maintaining quality documentation.

    • Additional Skills & Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • Minimum 35 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 in a fast-paced, deadline-driven environment.
  • Experience with FDA audits and inspection readiness.
  • Familiarity with electronic quality management systems (eQMS).
  • Comfortable working with a remote manager and providing weekly updates.
  • Willing to track work completed on a weekly basis and monitor deliverables.
  • Ability to organize schedule and work independently.

    • Work Environment

    This is a full-time onsite position. The work environment is collaborative, with opportunities to extend based on the progress of work and project needs.

    Job Type & Location

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

    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 1, 2025.

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    Qa Specialist • Lake Villa, IL, US