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