QA Floor Lead: Hands-on Quality & Compliance

Puretek Corporation; Los Angeles (CA); Sur place; USD 34 000 - 44 000; Plein temps

Résumé du poste

Puretek Corporation is seeking a Quality Assurance Coordinator to provide hands-on QA support in our manufacturing areas. The role focuses on QA spot checks during production, compounding, filling, packaging, and material handling to ensure cGMP compliance and quality standards.

The candidate will identify quality issues on the production floor, document observations, and support investigations, deviations, and CAPAs.

Qualifications

• 5+ years of experience in Quality Assurance, Quality Control, or manufacturing within GMP-regulated environments.
• Working knowledge of cGMP and Good Documentation Practices.
• Strong written and verbal communication skills.
• Ability to work independently and interact with Production and Quality personnel.

Responsabilités

• Perform routine and random QA walkthroughs and spot checks in production areas.
• Verify compliance with SOPs, batch records, work instructions, and cGMP requirements.
• Monitor raw material handling to prevent foreign-material contamination.
• Inspect production areas for contamination sources (plastic, fibers, debris, etc.).
• Ensure proper handling and opening of raw material bags and liners.
• Protect tanks, vessels, containers, and exposed products from contamination.
• Monitor gowning, hygiene, housekeeping, and line clearance controls.
• Document QA observations and follow up on corrective actions.
• Assist with investigations, deviations, CAPAs, and customer complaint investigations.

Connaissances

Quality Assurance

GMP / cGMP

Good Documentation Practices

Attention to detail

Written and verbal communication

Floor operations

Formation

Associate's or Bachelor's degree in Chemistry or related field

Description du poste

Puretek Corporation is seeking a Quality Assurance Coordinator to provide hands-on QA support in our manufacturing areas. The role focuses on QA spot checks during production, compounding, filling, packaging, and material handling to ensure cGMP compliance and quality standards.

The candidate will identify quality issues on the production floor, document observations, and support investigations, deviations, and CAPAs.