Kenneth Ebere
Richmond,TX
Summary
Detail-oriented and experienced Quality Auditor with over four years of expertise in performing comprehensive audits within regulated life sciences environments. Proven track record in evaluating compliance with GMP regulations and industry standards, including 21 CFR 210/211, 21 CFR 820, ICH guidelines, and 21 CFR 11. Adept at assessing the quality of APIs, excipients, packaging, and related manufacturing processes to ensure adherence to stringent quality and safety standards.
Overview
8
8
years of professional experience
Work History
Senior Quality Assurance Auditor
Ora, Inc
Andover, MA
01.2024 - Current
- Conducted comprehensive quality audits for suppliers within the pharmaceutical and medical device industries, ensuring compliance with GMP regulations and client-specific audit programs.
- Coordinated with SQA’s operations center to prepare and execute supplier quality audits, adhering to client audit schedules and integrating findings into client risk management frameworks.
- Developed detailed audit reports that highlighted findings, corrective actions, and recommendations, aligning with each client’s unique managed audit program.
- Trained and mentored junior auditors on audit processes, GMP regulations, and client-specific requirements, enhancing the team's overall performance and consistency in audit outcomes.
- Enhanced audit processes by implementing new tools and methodologies, which improved audit efficiency and effectiveness by 20%.
- Maintained accurate records of audit results, including any corrective actions taken.
Quality Assurance Specialist
ARCA Biopharma
Westminster, CO
06.2018 - 12.2020
- Led quality assurance activities including performing GMP-compliant audits of APIs, excipients, and packaging processes, ensuring adherence to 21 CFR 210/211 and ICH guidelines.
- Collaborated with cross-functional teams to identify quality issues, perform root cause analysis, and implement corrective actions to prevent recurrence.
- Conducted supplier assessments and audits to evaluate their adherence to quality standards and regulatory requirements, resulting in a 15% reduction in supplier-related quality incidents.
- Prepared and delivered detailed audit reports and presentations to senior management, providing insights and recommendations for process improvements.
- Developed and maintained strong working relationships with suppliers, fostering an environment of continuous quality improvement and compliance.
- Ensured compliance with all relevant safety regulations during testing phases.
- Conducted regular internal audits to identify non-conforming issues.
Quality Assurance Intern
United Therapeutics
College Station, TX
08.2016 - 05.2018
- Assisted senior auditors in performing audits of manufacturing processes and quality systems within the biologics and cosmetics sectors.
- Gained hands-on experience with audit preparation, execution, and reporting under the guidance of experienced auditors, familiarizing with GMP regulations and client-specific audit requirements.
- Conducted preliminary reviews of supplier documentation and audit reports, contributing to the identification of potential quality issues and non-compliance.
- Participated in internal quality meetings and audits, supporting the development and implementation of corrective and preventive actions (CAPAs).
- Acquired foundational knowledge in regulatory compliance and quality assurance practices, leading to successful completion of the internship and recognition for outstanding performance.
- Reviewed product specifications and provided input on potential areas for improvement.
Education
Bachelor of Science - Government And Public Administration
Imo State University
Imo State09-2008
Skills
- Audit Execution: Proficiency in planning, conducting, and reporting on quality audits of suppliers in the pharmaceutical, medical device, cosmetics, biologics, and animal health industries
- GMP Knowledge: In-depth understanding of Good Manufacturing Practices (GMP) and other relevant regulations (eg, 21 CFR 210/211, 21 CFR 820, ICH guidelines, 21 CFR 58, 21 CFR 11)
- Regulatory Compliance: Familiarity with compliance requirements for APIs, excipients, packaging, and related manufacturing processes
- Risk Management: Experience in integrating audit results into supplier risk management frameworks and addressing compliance gaps
- Subject Matter Expertise: Specialized knowledge in specific commodities such as APIs, raw materials, sterilization, components, laboratories, or distribution
- Attention to Detail: Strong ability to identify discrepancies, non-conformities, and areas for improvement during audits
- Problem-Solving: Capability to analyze complex issues and develop effective solutions in a regulated environment
References
References available upon request.
Timeline
Senior Quality Assurance Auditor
Ora, Inc
01.2024 - Current
Quality Assurance Specialist
ARCA Biopharma
06.2018 - 12.2020
Quality Assurance Intern
United Therapeutics
08.2016 - 05.2018
Bachelor of Science - Government And Public Administration
Imo State University
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