Senior QA Auditor

Quality Santa Cruz, California


Description

The Senior Quality Auditor independently verifies process, product and systems against standards to determine compliance.  Responsibilities include the completion of the four phases of an audit from preparation, through audit closure. The Senior Quality Auditor creates, develops and improves internal auditing programs, manages the Corrective and Preventive Actions (CAPA) program including the development and presentation of metrics to drive compliance, and drives Quality and Regulatory continuous improvement projects as needed.

 

Duties and Responsibilities

  • Oversee all internal and customer/supplier audit phases (Preparation, Performance, Reporting and follow-up/closure).
  • Maintain understanding of the standards and principles of auditing, related techniques (examining, questioning, evaluating & reporting) to determine Quality Management System (QMS) adequacy and deficiencies.
  • Audit internal documents, reports and systems for accuracy.
  • Analyze audit data to identify trends and issue reports & recommendations to management.
  • Prepare, support and lead third party audits (customer audits, NSF, Gluten Free, Kosher, SQF, GFCO, etc.) at the facility.
  • Manage the CAPA program. Lead the CAPA Board meetings and ensure follow-up on all CAPAs to closure.
  • Develop and present metrics around audits and CAPAs.
  • Utilize databases such as CAPA, complaints and plant metrics to optimize audits and strengthen continuous improvement opportunities resulting in cost savings or revenue enhancement.
  • Review and evaluate policies on a defined timescale.
  • Ensure audit records are complete and accurate.
  • Create and revise Standard Operating Procedures (SOPs) and Work Instructions (WI) based upon audit findings as necessary.

 

Required Qualifications

  • Bachelor’s degree in food science, technology, biology, microbiology or other related discipline.
  • 7 years’ experience within Quality Assurance/Quality Control focus including quality audits and CAPAs.
  • Thorough knowledge of cGMP documentation requirements and quality systems.
  • Advanced skills with Microsoft Office applications and Adobe Acrobat.

 

Preferred Qualifications

  • Knowledge of NSF, USP, Non-GMO, Gluten-Free, Organics Programs and relevant government regulations.
  • Experience with FDA Inspections.
  • Project management certification (PMP) and/or Certified Quality Auditor (CQA).
  • Bilingual in English/Spanish.

 

Physical Requirements

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.