Quality Assurance Specialist I- CAPA

Safety

Demonstrate safety performance behaviors and engage actively to promote.

Compliance

• Coordinates CAPA related activities to ensure timely closure and effective plans.
• Conducts internal audits as needed.
• Supports regulatory and third-party inspections for the site.
• Interfaces with outside regulatory and legal authorities as appropriate.
• Write, review, revise and approve procedures and specifications, as needed.
• Provide oversight for various quality system elements and tools.
• Works with quality, operations, distribution to ensure sound and timely decisions/investigations are made/written regarding nonconformance and root cause, CAPA analysis.
• Acts as a liaison between retail customers and operations / quality.

Managing, Planning and Directing

• Manage the CAPA system and associated CAPA board.
• Promote open communications within the site and with external contacts.
• Lead and execute various projects to enhance the site’s quality systems.
• Provide quality systems assistance for site functions.

Continuous Improvement

• Maintain and continually improve quality documentation and investigations.
• Write and review SOPs with a focus on improved content.
• Contribute to QPI improvement activities.

Qualifications

• Education: Bachelor's degree in a scientific, engineering, or other technical discipline required.
• Specialized training in 21 CFR Part 211, 21 CFR Part 820, ISO 9001:2000, and ISO 13485 preferred.
• Proficiency with database applications, including Microsoft Excel and Microsoft Access.
• Experience with quality management systems/databases such as D2 and CQMS preferred.
• Experience 3+ years of Quality Assurance experience in an FDA-regulated manufacturing or distribution environment required.
• Experience in pharmaceutical (drug) or medical device manufacturing preferred.
• Strong understanding of CAPA processes and quality system requirements, with the ability to identify root causes, evaluate corrective actions, and drive timely closure of CAPA records highly preferred.