On-the-Floor Packaging QA Specialist

Weil Group, Inc; Puerto Rico; On-site; USD 65,000 - 90,000; Full time

Job summary

Weil Group, Inc. seeks an experienced Packaging Quality Assurance (QA) Specialist to provide direct on-the-floor QA oversight for pharmaceutical packaging operations in a GMP-regulated setting.

You will ensure packaging activities, labeling, and documentation meet cGMP standards and regulatory requirements. The role involves line clearance verification, material reconciliation, in-process inspections, batch record review, and investigation of quality events.

Qualifications

• Bachelor's degree in a related technical discipline.
• Extensive hands-on QA experience in pharmaceutical packaging.
• Direct on-the-floor QA oversight in a GMP packaging environment.
• Strong working knowledge of cGMP, FDA requirements, and QA systems.
• Experience with packaging line clearance, labeling verification, packaging material reconciliation, and in-process quality inspections.
• Experience reviewing packaging batch records, production documentation, and GMP-related records.
• Experience supporting packaging deviations, investigations, root cause analysis, and CAPA processes.
• Knowledge of GDP and data integrity principles.
• Ability to identify packaging quality risks, evaluate compliance issues, and communicate appropriate actions.
• Excellent communication skills in English and Spanish.

Responsibilities

• Provide direct QA support on daily pharmaceutical packaging operations per cGMP and approved procedures.
• Conduct floor walkthroughs and inspections to verify procedural adherence and packaging quality.
• Perform line clearance activities before packaging operations, changeovers, and line restarts.
• Monitor product identification, labeling, packaging configuration, and material usage.
• Verify packaging equipment and processes operate per specifications.
• Document and observe packaging quality issues and GMP risks.
• Provide real-time QA guidance to packaging personnel during operations.

Skills

Analytical skills

Problem solving

Technical writing

Organizational skills

English & Spanish communication

Education

Bachelor's degree in Science/Engineering/Pharmaceutical Sciences

Tools

TrackWise

SAP

MES

EBR

Job description

Weil Group, Inc. seeks an experienced Packaging Quality Assurance (QA) Specialist to provide direct on-the-floor QA oversight for pharmaceutical packaging operations in a GMP-regulated setting.

You will ensure packaging activities, labeling, and documentation meet cGMP standards and regulatory requirements. The role involves line clearance verification, material reconciliation, in-process inspections, batch record review, and investigation of quality events.