Lead Quality Auditor

Location
Chatsworth, California (US)
Salary
$65,000-70,000
Posted
Jun 10, 2019
Ref
969089
Required Education
High School or equivalent
Position Type
Full time

General Description:

  • Identify, develop and maintain quality systems to ensure continuous improvement throughout the company in the management of audits to meet customer, regulatory and cGMP requirements. 
  • Work with cross-functional teams to facilitate and lead quality improvement activities.

Specific Duties and Responsibilities:

  • Ensure adherence to Quality System, and update SOP and Departmental Procedures as necessary.
  • Support internal and external audit programs.
    • Assist in development of checklists and participate in facility walk-throughs.
    • Document and incorporate observations into tracking logs for communication to relevant functions.
    • Develop and maintain general audit documentation, and ensure appropriate employee training conducted and completed as required.
    • Provide timely corrective action to audit findings and coordinate meetings to follow up with responsible parties for completion of actions are within established timelines.
  • Develop and monitor effectiveness checks upon completion of audit related Corrective and Preventive Action (CAPA).
  • Work with cross-functional teams to establish and maintain monthly metrics and KPIs for Quality; use data to drive improvements.
  • Ensure timely completion of reports including Non-Conformance Reports (NCR), Quality Alerts (QAR), and Quality deviations. Help relevant teams develop appropriate short and long term actions to address quality outages.
  • Create & maintain cohesive company information management pertaining to Quality (employee training documentation, equipment calibration master list, etc.).
  • Support the Executive Director of Quality & Regulatory on other special projects.

 

Educational Requirements:

  • Bachelor of Science in chemistry/related field, or combination of education and experience in cosmetics or related (FDA regulated) industry are required.

 

Qualifications:

  • Minimum 3-5 years of experience in Quality in an FDA regulated environment preferred. 
  • Experience with OTC or pharmaceutical products preferred.
  • Must be extremely detail oriented.
  • Must be able to work on numerous simultaneous projects to meet established timelines.
  • Excellent verbal and written communication skills required.