Quality Floor Shop 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. (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.

We are seeking a Quality Shop Floor Associate to provide real-time quality oversight and support within a regulated manufacturing environment. This individual will work directly with Manufacturing, Engineering, and Quality teams to ensure production activities comply with approved procedures, Good Manufacturing Practices (GMP), and applicable quality requirements.

Quality Floor Shop Specialist

Description

• 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 elevate 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.

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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose‑driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.