Packaging Quality Lead: Real-Time Compliance & Improvement

Becton Dickinson; El Paso (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

BD in El Paso, TX is seeking a Packaging Quality Oversight Leader to provide independent, real-time quality oversight of pharmaceutical packaging operations and controlled areas.

You will ensure compliance with master packaging records, procedures, and 21 CFR parts 820/210/211, drive line clearance, acceptance of batch records, and lead CAPA investigations. This role partners with operations to ensure quality is built into every step.

Qualifications

• Bachelor’s degree in Engineering, Science, Pharmacy, Packaging, or related technical discipline.
• Minimum 5 years of Quality experience in pharmaceutical/medical device manufacturing or packaging.
• Experience with FDA/health-authority inspections is strongly preferred.

Responsibilities

• Provide independent, real-time Quality oversight of pharmaceutical packaging operations and controlled areas.
• Ensure packaging activities comply with master packaging records, procedures, specifications, validated processes, and cGMP requirements.
• Oversee packaging line setup, line clearance, start-up, changeover, in-process checks, sampling, reconciliation, and line closeout.
• Verify coding, overprinting, vision-system challenges, barcode controls, label issuance, and reconciliation controls.
• Drive routine Quality presence on the packaging floor to identify and resolve compliance risks before product impact.
• Support timely batch record review, exception resolution, and disposition decisions with documented evidence.
• Apply root cause analysis and data-driven methods to packaging defects and recurring issues.
• Serve as Packaging Quality SME during internal audits, regulatory inspections, and remediation activities.
• Lead, coach, and develop Quality personnel supporting packaging operations.

Skills

Quality leadership

cGMP knowledge

Data integrity

CAPA investigations

Root cause analysis

Risk assessment

Statistical trending

Cross-functional influence

SAP familiarity

Vision systems

Education

Bachelor's degree in Engineering, Science, Pharmacy, Packaging, or related field

Master's degree preferred

Tools

SAP

Vision system applications

Electronic quality systems

Job description

BD in El Paso, TX is seeking a Packaging Quality Oversight Leader to provide independent, real-time quality oversight of pharmaceutical packaging operations and controlled areas.

You will ensure compliance with master packaging records, procedures, and 21 CFR parts 820/210/211, drive line clearance, acceptance of batch records, and lead CAPA investigations. This role partners with operations to ensure quality is built into every step.