Shop Floor Quality Specialist (GMP Compliance)

Pinnaql, Inc.; El Paso (TX); Sur place; USD 42 000 - 54 000; Plein temps

Résumé du poste

Validation & Engineering Group, Inc. is seeking a Quality Floor Shop Specialist to provide real-time quality oversight on the manufacturing floor in a GMP-regulated environment.

The role requires collaboration with Manufacturing, Engineering, and Quality teams to ensure adherence to approved procedures and quality standards. The ideal candidate will review documentation, support line clearance and start-up activities, and participate in CAPAs and investigations.

Qualifications

• High school diploma or GED required and GMP experience preferred.
• Experience in quality, manufacturing, inspection, or production within a regulated environment.
• Ability to read, understand, and follow written procedures and specifications.

Responsabilités

• Provide quality oversight and support on the manufacturing floor.
• Verify that manufacturing activities follow approved procedures, specifications, and GMP requirements.
• Review production documentation for accuracy, completeness, and compliance.
• Support line clearance, material verification, equipment readiness, and production start-up activities.
• Identify, document, and escalate quality issues and potential compliance concerns.
• Support investigations involving deviations, nonconformances, manufacturing events, and product-quality issues.
• Participate in root-cause analysis and corrective and preventive action activities.
• Assist with the inspection, review, and disposition of materials and products.
• Collaborate with Manufacturing and other departments to resolve quality issues promptly.
• Maintain accurate and timely records in accordance with data-integrity requirements.
• Support audits, inspections, and continuous-improvement initiatives.
• Perform other quality-related responsibilities as assigned.

Connaissances

Attention to detail

Communication

Problem solving

Teamwork

Reading procedures

Formation

High school diploma or GED

Bachelor's degree in Science/Engineering (plus)

Outils

Electronic QMS

Description du poste

Validation & Engineering Group, Inc. is seeking a Quality Floor Shop Specialist to provide real-time quality oversight on the manufacturing floor in a GMP-regulated environment.

The role requires collaboration with Manufacturing, Engineering, and Quality teams to ensure adherence to approved procedures and quality standards. The ideal candidate will review documentation, support line clearance and start-up activities, and participate in CAPAs and investigations.