Quality Assurance Affairs Specialist


UTAK Laboratories
25020 Avenue Tibbitts
Valencia, CA 91355
United States

Category
Application Closing Date
7/31/2019
Manages Others
No
Experience Required
Yes
Degree Required
No
Security Clearance Required
No
Employment Type
Employee
Work Schedule
Full-Time

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.
Employer
UTAK Laboratories
Christina Plutchak
25020 Avenue Tibbitts
CA 91355
United States