GMP Floor QA Specialist – Pharmaceutical Manufacturing

Weil Group, Inc; Puerto Rico; On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Bilingual work environment

Job summary

Weil Group, Inc is seeking an experienced Manufacturing Quality Assurance (QA) Specialist to provide direct, on-the-floor QA oversight for pharmaceutical manufacturing in a GMP setting. You will ensure production activities, equipment, documentation, and personnel practices meet cGMP and FDA requirements, with real-time guidance and risk assessments.

You will review batch records, support deviations and CAPA, and collaborate with Manufacturing, Engineering, Validation, and Quality teams to

Qualifications

• Bachelor's degree in Science, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related technical discipline.
• Extensive hands-on Quality Assurance experience supporting pharmaceutical or biopharmaceutical manufacturing operations.
• Direct, on-the-floor QA oversight in a GMP-regulated environment.
• Strong working knowledge of cGMP regulations, FDA requirements, and QA systems.
• Experience reviewing batch records, production documentation, and GMP-related records.
• Experience supporting deviations, investigations, root cause analysis, and CAPA processes.
• GDP, data integrity principles, change control familiarity, and strong communication in English and Spanish.

Responsibilities

• Provide direct QA support and oversight for daily pharmaceutical manufacturing operations in accordance with cGMP.
• Conduct floor walkthroughs and inspections to verify compliance with procedures and quality requirements.
• Monitor critical activities such as equipment prep, line clearance, material handling, and in-process controls.
• Verify batch records against SOPs and process parameters; escalate quality issues promptly.
• Support deviations, investigations, CAPA, and containment actions with cross-functional teams.
• Assist change controls and quality system improvements to strengthen compliance.

Skills

On-the-floor QA oversight

cGMP knowledge

GMP documentation

Problem solving

English/Spanish bilingual

Education

Bachelor's degree in Science/Engineering/Pharma

Tools

TrackWise

MES

Electronic batch records (EBR)

SAP

Job description

Weil Group, Inc is seeking an experienced Manufacturing Quality Assurance (QA) Specialist to provide direct, on-the-floor QA oversight for pharmaceutical manufacturing in a GMP setting. You will ensure production activities, equipment, documentation, and personnel practices meet cGMP and FDA requirements, with real-time guidance and risk assessments.

You will review batch records, support deviations and CAPA, and collaborate with Manufacturing, Engineering, Validation, and Quality teams to