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Quality Specialist - Validation

Quality Specialist - Validation

ActalentDurham, NC, US
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Job Description

Job Description

Job Title : Quality Specialist - Validation

Job Description

We are seeking a dedicated Quality Specialist - Validation to join our team. This role involves developing and maintaining cGMP operating procedures related to process, computer systems, and equipment validation, ensuring compliance with SOPs, and aligning with regulatory standards. The position requires collaboration with multiple departments to facilitate validation testing, analyze data, and prepare comprehensive validation reports.

Responsibilities

  • Assist in the development of cGMP operating procedures related to process, computer systems, and equipment validation.
  • Assure compliance with SOPs upon implementation and propose corrective actions as needed.
  • Communicate with Field Quality / Operations and other Operational and Quality Assurance personnel on compliance and cGMP issues.
  • Ensure validation approaches meet regulatory expectations and standards.
  • Write and execute test cases to validate critical control points, user requirements, and functional designs.
  • Facilitate validation testing to ensure timely and documented approval before routine use.
  • Analyze validation data to ensure acceptance criteria are met.
  • Prepare validation summaries and reports for distribution.
  • Ensure milestones and timelines are met for assigned projects.
  • Evaluate the adequacy of corrective actions and participate in evaluating processes, systems, and equipment needs.
  • Prepare validation equipment for use and evaluate upon return.
  • Identify actions to add, remove, or revalidate processes, systems, and equipment.
  • Track and monitor process / system and equipment calibration failures / events.
  • Provide feedback to Donor Center management regarding requirements and results from validation processes.
  • Monitor and trend customer complaints and nonconformance related to equipment failures.

Essential Skills

  • Strong knowledge of current Good Manufacturing Practices (cGMPs) and standard operating procedures.
  • Excellent quantitative and analytical skills.
  • Strong oral and written communication skills.
  • Critical thinking and problem-solving skills.
  • Ability to identify errors and provide corrective actions.
  • Team collaboration skills.
  • Proficiency in Microsoft Office applications and computer applications used in the Donor Centers.

    • Additional Skills & Qualifications

  • Experience in developing and implementing quality systems.
  • Knowledge of FDA and quality assurance / control documentation.

    • Work Environment

    Work is performed in both office and laboratory / manufacturing settings, requiring adherence to safety and quality standards.

    Job Type & Location

    This is a Contract position based out of Durham, North Carolina.

    Pay and Benefits

    The pay range for this position is $35.00 - $40.00 / 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 Durham,NC.

    Application Deadline

    This position is anticipated to close on Oct 15, 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.

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    Quality Specialist • Durham, NC, US