Quality Floor Shop Specialist

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

About the role

The Quality Shop Floor Associate provides real‑time quality oversight and support within a regulated manufacturing environment, working directly with Manufacturing, Engineering, and Quality teams to ensure production activities comply with approved procedures, Good Manufacturing Practices (GMP), and applicable quality requirements.

Responsibilities

• 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 (CAPA) 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.

Minimum Qualifications

• High school diploma or GED required.
• Previous GMP experience is required.
• Experience in quality, manufacturing, inspection, or production within a regulated environment.
• Understanding of good documentation practices and data‑integrity principles.
• Ability to read, understand, and follow written procedures and specifications.
• Strong attention to detail, communication, and problem‑solving skills.
• Ability to work effectively in a fast‑paced, team‑oriented manufacturing environment.
• Availability to work assigned shifts and provide on‑site shop‑floor support.

Preferred Qualifications

• Bachelor’s degree in Science, Engineering, Quality, or a related field is a plus but not required.
• Experience in the medical‑device, pharmaceutical, biotechnology, or other FDA‑regulated industry.
• Experience supporting deviations, nonconformances, investigations, CAPAs, and change controls.
• Familiarity with electronic quality and manufacturing documentation systems.
• Bilingual English and Spanish is preferred.