Quality Assurance Affairs Specialist

UTAK Laboratories
25020 Avenue Tibbitts
Valencia, CA 91355
United States

Application Closing Date
Manages Others
Experience Required
Degree Required
Security Clearance Required
Employment Type
Work Schedule

Job Description

The Quality Assurance Affairs Specialist ensures compliance to all relevant regulation and standards, including ISO; conducts audits and reviews/analyzes data and documentation to assure achievement of UTAK’s Quality goals.

  • Comply with UTAK’s policies, procedures, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations.
  • Establish and maintain procedures to control all documents and records.
  • Ensure compliance with record retention per corporate policy. Prepare records for destruction.
  • Drive continual improvement through all elements of the Quality Management System.
  • Develop and maintain internal / external audit schedule, conduct audits and track action item closure and effectiveness per ISO written standards.
  • Support external audits or investigations.
  • Provide or coordinate training to ensure adherence to audit schedule, ISO standards and proper procedures as required.
  • Analyze data for metrics:
    • Investigate quality issues using data analysis tools.
    • Make recommendations and investigate proposed solutions.
  • Establish and maintain procedures to control labeling activities including label creation, change control, and linkages to associated documents.
  • Establish and maintain procedures for change control:
    • Develop and implement change control process, label change control process, and process change control procedures.
    • Creation, development, implementation and maintenance of an electronic change control system.
    • Develop appropriate training when processes have been revised,
  • Maintain electronic training records.
  • Ensure regulations and standards are available and up-to-date.
  • Maintain equipment master files.
  • Review and write/revise Quality Systems SOP’s, process flow charts, certificate of analysis, specifications and other quality related documentation on a continuous basis to support continual improvement.
  • Participate on cross functional teams to improve processes and associated procedures.
  • Deliver regular and reliable attendance and punctuality.
  • Complete product registrations to regulatory bodies for commercialization
Job Requirements
Bachelor’s degree in Chemistry or Biology or related field preferred; previous experience in Quality Systems Regulations. Previous manufacturing and laboratory experience preferred; or an equivalent combination of education and experience.
UTAK Laboratories
Christina Plutchak
25020 Avenue Tibbitts
CA 91355
United States