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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.Job Description
We are the makers 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 MedTech 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.
Responsibilities:
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
Education and Experience:
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, ISO13485 and ISO 14971 (US, EU, Canada) for medical devices required or drug products preferred.
Knowledge and Skills:
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
COMPUTER SKILLS:
Basic Commercial software, MS-Word, MS-Excel, Statistical packages.
OTHER SKILLS:
Must be a team player.
Bilingual Preferred.
Must have Good written and oral communication skills.
Must have good time and project management skills.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
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