Job Title: Quality Specialist - ValidationJob Description The Quality Specialist - Validation ensures adherence to current Good Manufacturing Practices (cGMP) and FDA Quality Systems throughout the evaluation, review, and approval of validation and quality assurance/control documentation. This role is essential in maintaining high-quality standards and compliance within the organization. Responsibilities + Assist in the development of cGMP operating procedures related to process, computer systems, and equipment validation. + Assure compliance with SOPs upon implementation and investigate additional corrective actions as needed. + Communicate with Field Quality/Operations and other personnel regarding Donor Center compliance and cGMP issues. + Ensure validation approaches align with regulatory expectations and industry standards. + Write and execute test cases to validate critical control points, user requirements, and functional designs. + Interact with Donor Center and Field Quality/Operations personnel to facilitate validation testing, ensuring timely and documented approval prior to routine use. + Analyze validation data to ensure acceptance criteria are met and assist in writing validation summaries. + Ensure milestones and timelines are met on assigned projects and prepare validation reports for distribution. + Evaluate adequacy of corrective actions and participate in the evaluation of processes, systems, and equipment needs. + Prepare validation equipment for use at the Donor Center and evaluate upon return. + Identify and determine actions for adding, removing, and/or revalidating processes, systems, and equipment. + Track and monitor process/system failures/events and provide feedback to Donor Center management. + Monitor and trend customer complaints and nonconformance related to equipment failures. Essential Skills + Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. + Excellent quantitative and analytical skills. + Exceptional oral and written communication skills. + Strong critical thinking and problem-solving abilities. + Ability to identify errors and provide corrective action. + Proficient in Microsoft Office applications and computer applications used in the field. Additional Skills & Qualifications + Bachelor's degree. Work Environment The work is performed in both office and laboratory/manufacturing environments with exposure to biological fluids and potential infectious organisms. There is occasional exposure to extreme cold and high noise levels in production areas, as well as electrical office and laboratory equipment. Personal protective equipment, such as protective eyewear, garments, and gloves, is required. The role involves sitting for 4-6 hours daily, with occasional standing, bending, and twisting. Repetitive hand movements and precise coordinated finger movements are necessary. Lifting and carrying objects up to 50lbs may be required. Near and far vision correctable in one eye to 20/30 and to 20/100 in the other eye is essential. The ability to communicate complex information effectively and follow instructions is crucial. 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 Aug 1, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.