Quality Site CAPA Lead

Job Description Summary

The Quality CAPA Specialist ensures that the CAPA processes, systems and operations within the pharmaceutical company comply with internal policies and cGMP standards and regulatory requirements. This role is responsible for providing guidance and coaching to teams on developing robust root cause analysis, sound action plans, and effectiveness monitoring strategies. The CAPA Specialist ensures that CAPAs are properly implemented and verified for effectiveness, maintaining the integrity of products and quality system.

We are a maker of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Execute and administer activities associated with Quality System requirements including, but not limited to, CAPA, Situation Analysis, root cause investigations & audit findings.
• Ensure investigation outcome, root cause analysis, and resulting solutions (CAPAs) are completed in a timely and effective manner, in compliance with standards.
• Serve as site CAPA lead for El Paso site and oversee the corrective and preventive action system (CAPA) including analyzing the proposed actions in order to verify that the realized solutions will be effective; determining if the scope of the action is broad enough; and providing collaborative feedback to CAPA owners.
• Assist junior colleagues in areas of root cause analysis and quality problem solving.
• Facilitate functional groups to determine root cause failure using standard failure analysis tools.
• Maintain systems for tracking CAPAs and audit findings, perform trending analysis activities, and present information as appropriate to management.
• Facilitate and lead CAPA Review Board meetings.
• Apply sound, systematic, problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Partner with cross‑site and cross‑functional resources in the pursuit of continuous improvement and provide quality systems guidance as necessary.
• Conduct and participate in internal and external Quality System audits to assess the compliance with FDA regulations, ISO standards, MDSAP, EU MDR and any other international regulations and internal requirements.
• Acquire and analyze information for the purposes of authoring and reviewing technical documents along with informational and decision‑making management reports.
• Maintain and adhere to departmental processes and systems to ensure regulatory compliance.
• Support the generation, publishing, trending, and monitoring of Quality metrics.
• Perform other duties as assigned.

• Bachelor’s degree in engineering or other technical discipline equivalent required.
• Experience speaking as CAPA SME during inspections and/or audits preferred.
• Understanding of statistical methods, quality tools and methodologies, (e.g., Four step, Five Whys, Plan‑Do‑Check‑Act (PDCA), A3, Six‑sigma, Eight Disciplines Problem Solving (8D) and/or Problem‑Solving Methodology (PSM)) in the areas of investigations and CAPAs.
• Applied Knowledge of the requirements of FDA QSR, ISO
  13485 and ISO 14971 (US, EU, Canada) for medical devices required or drug products preferred.

• 3-5 years successful experience in manufacturing quality assurance.
• Experience in FDA GMP or ISO requirements.
• Experience in Documentation.
• ASQC Certified Quality Auditor Preferred.
• Auditing Experience.

• Basic commercial software, MS‑Word, MS‑Excel, statistical packages.

• Must be a team player.
• Bilingual Preferred.
• Must have good written and oral communication skills.
• Must have good time and project…