PACKAGING QUALITY ASSURANCE (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

PACKAGING QUALITY ASSURANCE (QA) SPECIALIST

• Biotech/Pharmaceutical

Job Overview

We are seeking an experienced Packaging Quality Assurance (QA) Specialist to provide direct, on-the-floor quality oversight and support for pharmaceutical packaging operations within a GMP-regulated manufacturing environment.

The ideal candidate will have extensive hands-on experience in pharmaceutical packaging quality assurance, ensuring that packaging activities, equipment, materials, labeling processes, and documentation comply with established procedures, regulatory requirements, and quality standards.

This position requires active involvement in packaging floor operations, including line clearance verification, packaging material reconciliation, in-process inspections, batch record review, and investigation of quality events. The specialist will collaborate closely with Packaging Operations, Manufacturing, Engineering, Validation, and Quality teams to ensure packaging processes consistently meet product quality, safety, and regulatory expectations.

Key Responsibilities On-the-Floor Quality Assurance & Packaging Oversight

• Provide direct QA support and oversight for daily pharmaceutical packaging operations, ensuring compliance with current Good Manufacturing Practices (cGMP), approved procedures, and established quality standards.
• Conduct routine packaging floor walkthroughs and inspections to verify compliance with operational procedures, documentation practices, and packaging quality requirements.
• Perform or verify line clearance activities before packaging operations, product changeovers, and line restarts, in accordance with approved procedures.
• Monitor packaging activities to ensure correct product identification, labeling, packaging configuration, and material usage.
• Verify that packaging equipment, production lines, and associated processes operate according to approved specifications and procedures.
• Identify, document, and observe packaging-related quality issues, procedural discrepancies, and potential GMP compliance risks.
• Provide real-time quality guidance and support to packaging personnel during routine operations and unexpected events.

Packaging Materials, Labeling & Reconciliation

• Verify the proper identification, issuance, handling, usage, and reconciliation of printed packaging materials, labels, cartons, inserts, and other packaging components.
• Ensure packaging materials and labeling information correspond to approved product specifications and applicable batch documentation.
• Support verification of packaging material reconciliation, including quantities issued, used, rejected, returned, and destroyed, as applicable.
• Monitor packaging operations to prevent product mix-ups, labeling errors, cross-contamination, and other potential quality risks.
• Verify compliance with established procedures for packaging material segregation, traceability, and inventory control.
• Support investigations related to packaging material discrepancies, labeling errors, reconciliation differences, and packaging defects.

Batch Record Review & Documentation Compliance

• Review packaging batch records, electronic records, equipment logbooks, line clearance documentation, and associated quality records for accuracy, completeness, and GMP compliance.
• Verify adherence to Good Documentation Practices (GDP) and applicable data integrity requirements.
• Identify documentation discrepancies, missing information, and procedural inconsistencies, coordinating timely resolution with Packaging Operations.
• Support packaging batch record reconciliation and documentation review activities associated with batch disposition.
• Ensure packaging documentation accurately reflects executed operations, material usage, equipment status, and required quality verifications.

Deviations, Investigations & CAPA

• Support the identification, documentation, and investigation of packaging deviations, nonconformances, labeling discrepancies, and quality events.
• Collaborate with Packaging Operations and technical teams to evaluate potential product quality impacts and determine appropriate containment actions.
• Participate in root cause investigations involving packaging equipment, materials, procedures, personnel practices, and process execution.
• Review and support the implementation of Corrective and Preventive Actions (CAPA) addressing packaging-related quality issues.
• Monitor corrective action effectiveness and support timely closure of investigations and quality events.
• Provide QA input regarding packaging discrepancies, procedural deviations, and potential compliance risks.

Change Control & Quality Systems

• Support the evaluation and implementation of change controls affecting packaging processes, equipment, materials, labeling, and operational procedures.
• Review proposed changes to assess potential impacts on product quality, packaging integrity, regulatory compliance, and validated processes.
• Collaborate with Engineering, Validation, and Packaging teams to ensure appropriate quality oversight during equipment modifications, packaging line improvements, and process changes.
• Support the review and revision of Standard Operating Procedures (SOPs), packaging instructions, and other controlled documents.
• Participate in quality improvement initiatives to strengthen packaging compliance, process consistency, and operational efficiency.

GMP Compliance, Audits & Continuous Improvement

• Ensure packaging activities comply with applicable FDA regulations, including 21 CFR Parts 210 and 211, and established cGMP requirements.
• Support internal audits, regulatory inspections, and quality assessments related to pharmaceutical packaging operations.
• Identify opportunities to improve packaging quality controls, documentation practices, material reconciliation, and operational compliance.
• Provide quality guidance to packaging personnel regarding GMP expectations, labeling controls, line clearance, and documentation requirements.
• Participate in cross-functional meetings to address packaging quality concerns, operational challenges, and continuous improvement initiatives.
• Promote a strong quality culture through proactive communication, risk identification, and consistent application of quality requirements.

Qualifications & Requirements Mandatory Qualifications

• Bachelor's degree in Science, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical discipline.
• Extensive hands-on Quality Assurance experience supporting pharmaceutical or biopharmaceutical packaging operations.
• Demonstrated experience providing direct, on-the-floor QA oversight in a GMP-regulated packaging environment.
• Strong working knowledge of cGMP regulations, FDA requirements, and pharmaceutical packaging quality 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.
• Working knowledge of change control, Good Documentation Practices (GDP), and data integrity principles.
• Ability to identify packaging quality risks, evaluate compliance issues, and communicate appropriate actions.
• Strong analytical, problem-solving, technical writing, and organizational skills.
• Ability to work independently and effectively collaborate with Packaging Operations, Engineering, Validation, Manufacturing, and Quality teams.
• Excellent communication skills in English and Spanish.
• Ability to work directly in packaging areas and support operational schedules as required.

Preferred Qualifications

• Previous experience supporting commercial pharmaceutical or biopharmaceutical packaging operations.
• Experience with primary and secondary pharmaceutical packaging processes.
• Familiarity with automated packaging lines, labeling systems, serialization, and packaging inspection equipment.
• Experience with packaging equipment qualification, process validation, and packaging line changeovers.
• Familiarity with electronic batch records (EBR), Manufacturing Execution Systems (MES), and electronic quality management systems.
• Experience with quality systems such as TrackWise, SAP, or similar GMP-regulated platforms.
• Knowledge of packaging component specifications, product traceability, labeling controls, and material reconciliation practices.
• Experience participating in FDA inspections, internal audits, or regulatory compliance assessments.
• Familiarity with packaging defect investigations, equipment-related quality events, and batch disposition processes.

Weil Group is proud to be an Equal Employment Opportunity Employer.