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Regulatory Audit Support Consultant

Regulatory Audit Support Consultant

AstrixOntario, CA, US
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Job Description

Quality Control Specialist - Regulatory Audit Support

Location : Ontario, CA (On-site Required)

Employment Type : Contract (2-3 week assignment)

Schedule : Monday - Friday, 8 : 30 AM - 5 : 00 PM (flexible based on audit schedule)

Compensation : $40-$50 / hour

Start Date : Immediate

Position Overview

We are seeking an experienced Quality Control Specialist to provide critical support during an upcoming NSF audit at our nutraceutical manufacturing facility. This is an excellent opportunity for a quality professional to take a leadership role in ensuring regulatory compliance and supporting audit preparations in a collaborative, small-team environment.

Key Responsibilities

  • Develop and review raw materials specifications and sampling procedures.
  • Maintain comprehensive document control systems.
  • Review and update batch records, Certificates of Analysis (COAs), and Standard Operating Procedures (SOPs).
  • Validate finished product and in-process testing documentation.
  • Organize calibration logs and instrument maintenance records.
  • Serve as liaison during auditor facility tours.
  • Provide technical explanations for Out-of-Specification (OOS) and Out-of-Control (OOC) results.
  • Support Corrective and Preventive Actions (CAPA) initiatives.

Required Qualifications

  • Essential : NSF audit experience with proven track record.
  • Preferred : Softgel manufacturing experience.
  • Strong background in document control and management.
  • HACCP certification highly preferred.
  • Comprehensive understanding of current Good Manufacturing Practices (cGMPs).
  • 2-3 years of hands-on experience in dietary supplement manufacturing.
  • High school diploma minimum; nutraceutical industry background required.
  • This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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    Regulatory Consultant • Ontario, CA, US

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