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Sr.Staff Quality Specialist
| Company | Becton Dickinson |
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| Location | San Diego, CA, USA |
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| Salary | $155900 – $257300 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Expert or higher |
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Requirements
- Bachelor’s degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences)
- Minimum 11 years of experience in quality management with a focus on CAPA, audits, and regulatory compliance
- Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g., FDA, ISO, GMP)
- Proficiency in CAPA software and auditing tools (e.g., TrackWise)
- Excellent analytical, problem-solving, and communication skills
Responsibilities
- Oversee the transition of audit findings from OneAudit system to the Corrective and Preventive Action (CAPA) in TrackWise
- Collaborate with cross-functional stakeholders to ensure proper, timely, and accurate transitions
- Maintain frequent communication on pertinent details of transitions with appropriate contacts
- Manage internal audit observations
- Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies
- Identify appropriate owners for audit findings and monitor audit phase timeliness
- Serve as a liaison between owners and internal auditors
- Identify areas of non-compliance and work with relevant departments to develop corrective action plans
- Perform administrative tasks within the audit system, where appropriate
- Stay up to date with relevant industry regulations and standards
- Ensure audit responses are complying and lead efforts to adapt to regulatory changes
- Prepare compliance reports for senior management
- Lead and participate in continuous improvement initiatives related to monitoring the audit program and overseeing audit phase execution
Preferred Qualifications
- Certification in Quality Management (e.g., Certified Quality Auditor, Certified Lean Six Sigma) is a significant advantage
- Exceptional attention to detail and a commitment to data accuracy
- Strong organizational and time management skills
- Ability to lead and collaborate effectively in a cross-functional team environment
- Analytical mindset with a passion for deriving insights from data
- Demonstrated integrity in handling sensitive data and adherence to ethical standards
