QA Auditor (Manufacturing)

POSITION SUMMARY

Responsible for ensuring compliance and supporting continuous quality improvement within the production area. This role monitors daily manufacturing activities to ensure adherence to SOPs and cGMP requirements and follows through with appropriate actions, including escalation and enforcement of quality standards.

OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

• Observe and monitor in-process production activities to ensure compliance with cGMP requirements
• Verify job setup, line clearance, and startup activities, including completion of required checklists
• Ensure cleanliness, sanitation, hygiene, and housekeeping standards are maintained in assigned areas
• Perform in-process inspections, sampling, and testing to verify compliance with specifications
• Inspect and monitor in-process materials and finished goods for quality and compliance
• Review batch records and production documentation for accuracy, completeness, and real-time documentation practices
• Audit electronic production records (e.g., PCLE), including checklists, data entries, releases, and rejections
• Accurately record inspection results, process checks, and activities in electronic systems
• Ensure assigned production areas remain in a continuous state of audit readiness (clean, organized, and compliant)
• Work directly with operators to ensure processes align with SOPs, work in