Quality Assurance Analyst

Full Time
Naperville, IL 60540
Posted
Job description

INTRODUCTION

Orochem Technologies Inc. has been a trusted manufacturer of laboratory consumables for 26 years, serving the food and pharmaceutical industries. As an industry leader in contract purification of food ingredients and dietary supplements, we take pride in delivering exceptional quality and reliable solutions to our clients. We are excited to announce an opening for a Quality Assurance Analyst in our team.

DUTIES & RESPONSIBILITIES

  • Provide support for daily quality operations and activities of the quality management system.
  • Review protocols and reports related to facility, utility, and equipment commissioning, qualification/requalification, process/method validation, and other cGMP activities from a quality perspective to ensure compliance with internal requirements and technical standards.
  • Conduct internal audits, annual product reviews, and product quality reviews.
  • Ensure that all food safety, quality assurance, and regulatory programs comply with internal requirements, and regulatory guidelines, and documented accordingly.
  • Prepare and execute third-party audits, and FDA and USDA food safety system assessments. Take appropriate corrective actions based on findings.

REQUIREMENTS

  • A bachelor's degree or higher, with a minimum of 2 years of experience in a quality assurance role is required.
  • Candidates with at least 2 years of quality assurance experience in food or nutraceutical manufacturing are preferred.
  • Candidates with 5+ years of experience in a GMP food manufacturing setting may be considered for a senior-level position.
  • Strong knowledge of FDA, USDA, GFSI, and FSSC22000 requirements is essential.
  • Familiarity with FDA guidelines 21 CFR 110 and 117 is preferred.
  • HACCP certification is required.
  • Strong experience in food safety is necessary.

Job Type: Full-time

Pay: $62,895.00 - $75,000.00 per year

Benefits:

  • 401(k)
  • Health insurance
  • Paid time off

Experience level:

  • 2 years
  • 5 years

Schedule:

  • 8 hour shift

Ability to commute/relocate:

  • Naperville, IL 60563: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • Quality assurance: 2 years (Required)
  • CGMP: 5 years (Required)

Work Location: In person

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