GMP Floor Quality Assurance Specialist

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 40,000 - 65,000; Full time

Job summary

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

You will collaborate with Manufacturing, Engineering and Quality teams to ensure procedures, GMP, and data integrity are followed, and to review documentation for accuracy. The role emphasizes deviations investigation support, root-cause analysis participation, and on-site shift coverage to maintain compliant production and

Qualifications

• High school diploma or GED required.
• GMP experience 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.

Responsibilities

• Provide quality oversight and support on the manufacturing floor.
• Verify 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 elevate quality issues and potential compliance concerns.
• Support investigations involving deviations, nonconformances, manufacturing events, and product-quality issues.
• Participate in root-cause analysis and CAPA activities.
• Assist with 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.]
• Preferred: experience in medical-device/pharma/biotech FDA-regulated industries.
• Familiarity with electronic quality and manufacturing documentation systems.
• Bilingual English and Spanish is preferred.

Skills

GMP experience

Quality oversight

Data integrity

Documentation reading

Attention to detail

Education

Bachelor's degree (preferred)

Job description

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

You will collaborate with Manufacturing, Engineering and Quality teams to ensure procedures, GMP, and data integrity are followed, and to review documentation for accuracy. The role emphasizes deviations investigation support, root-cause analysis participation, and on-site shift coverage to maintain compliant production and