Quality Assurance Coordinator

**Please note that at Puretek, we do not use AI to filter applications. Every resume is seen and assessed by a qualified human being**

Position Summary

We are seeking a Quality Assurance Coordinator to provide hands-on QA support and oversight in our manufacturing and compounding areas.

This role primarily focuses on conducting routine and random QA spot checks during production, compounding, filling, packaging, and material handling to ensure compliance with cGMP requirements, approved procedures, and quality standards.

This position will be highly visible on the production floor and will play an important role in identifying and preventing potential quality issues.

Key Responsibilities

• Perform routine and random QA walkthroughs and spot checks in production, compounding, filling, packaging, and warehouse areas.
• Verify compliance with approved SOPs, batch records, work instructions, and cGMP requirements.
• Monitor raw material handling and charging activities to help prevent foreign-material contamination.
• Inspect production areas for potential sources of contamination, including plastic, cardboard, fibers, equipment debris, damaged gaskets, packaging fragments, and other foreign particles.
• Verify proper handling and opening of raw material bags and liners.
• Confirm that tanks, vessels, containers, and exposed products are properly protected from contamination.
• Monitor gowning, hygiene, housekeeping, equipment cleanliness, line clearance, and material status controls.
• Verify completion of required in-process checks and documentation.
• Identify GMP deficiencies and communicate observations immediately to Production and QA management.
• Document QA observations and follow up on corrective actions.
• Support investigations, deviations, CAPAs, and customer complaint investigations.
• Assist with trending recurring GMP and foreign-material observations.
• Escalate significant product-quality or contamination risks to QA management.

Qualifications

• Associate's or Bachelor's degree in Chemistry, Biology, Pharmaceutical Science, Food Science, Quality, or a related field preferred.
• 5+ years of experience in Quality Assurance, Quality Control, or manufacturing within a pharmaceutical, dietary supplement, cosmetic, food, or other GMP-regulated environment preferred.
• Working knowledge of cGMP and Good Documentation Practices.
• Strong attention to detail and observational skills.
• Ability to identify potential contamination and quality risks.
• Strong written and verbal communication skills.
• Ability to work independently and interact effectively with Production and Quality personnel.
• Comfortable spending a significant portion of the workday on the manufacturing floor.

What We Are Looking For

The ideal candidate is proactive, detail-oriented, and comfortable working directly in manufacturing areas. This individual should be able to identify abnormal conditions, raise concerns promptly, and work collaboratively with Production to prevent quality issues before they affect finished product.

This is a hands-on QA floor position, not primarily a desk-based or documentation role.