Quality Specialist - Validation

Quality Specialist - Validation

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.