Quality Assurance Associate

Job Summary:

The Quality Assurance Associate supports our quality program by performing testing, inspections and record keeping. The QA/QC Associate will play a key role in supporting both the Quality Assurance and Quality Control functions. You will be responsible for conducting inspections, reviewing documentation, ensuring compliance with regulatory standards (FDA, GMP), and supporting the testing and release of raw materials, in-process goods, and finished products.

Key Responsibilities:

  • Thorough knowledge or understanding of GMP regulations as it pertains to 21 CFR Part 111.
  • Inspects in-coming raw material and packaging supplies per established specifications.
  • Create product specifications for all materials, active ingredients and finished products.
  • Help create SOPs and forms for all manufacturing and packaging processes.
  • Involved in the training of GMP procedures and methods for internal personnel.
  • Supports in-house and third-party testing of raw materials and finished products samples
  • Direct, coordinate, review results from lab and advise personnel and outsource labs in test procedures for analyzing components and physical properties of materials.
  • Be able to maintain document control system with change control process.
  • Maintain proper filling of QC related documents as per GMP procedures.
  • Be involved with FDA, 3rd party certification and customer audits.
  • Review product labeling for technical accuracy and compliance with applicable regulatory standards
  • Be involved with Adverse Event Reports, product complaints, recalls, deviations, OOS and CAPA.
  • Assist with internal audits.
  • Maintain sample and retain inventory.

Qualifications and skills:

  • Associate’s or Bachelor’s degree in Chemistry or related sciences
  • 3+ years of QA/QC experience in a nutraceutical, pharmaceutical, or food manufacturing environment preferred.
  • Knowledge of cGMP and industry best practices.
  • Strong attention to detail and documentation skills.
  • Familiarity with lab instruments and testing procedures.
  • Ability to work independently and as part of a team in a fast-paced environment.
  • Strong written and oral communication skills

Job Type: Full-time

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