Quality Assurance Specialist III
21 hours ago
Job Summary:
PackGene Biotech Inc. is seeking a highly motivated Quality Assurance Specialist III to join our dynamic QA department. As a key member of our team, you will be responsible for ensuring compliance with cGMP regulatory requirements and maintaining our quality management system.
Key Responsibilities:
- Compliance Monitoring: Establish and trend quality metrics to ensure compliance with cGMP requirements and PackGene policies.
- Auditing: Conduct internal and external audits to assess compliance with quality management systems and regulatory requirements.
- Document Control: Maintain document control and archival systems, and develop, review, and approve GMP documents.
- Training: Manage training programs and identify training needs with department managers.
- Risk Management: Identify quality compliance risks and develop mitigation strategies with cross-functional teams.
- Continuous Improvement: Collaborate with teams to identify and implement process improvements that enhance product quality and compliance.
- CAPA, Deviation, Change Control Management: Oversee these processes and drive timely closure.
- Regulatory Submissions: Assist in preparing regulatory submissions and responses to regulatory agency inquiries.
- Quality Metrics: Develop and monitor key quality metrics to assess the effectiveness of quality assurance processes.
Requirements:
- Bachelor's degree with 4+ years of experience in biotechnology, biopharmaceutical, or CDMO industry.
- In-depth knowledge of regulatory requirements, quality management systems, auditing, and industry best practices.
- Experience authoring, reviewing, and approving GMP documents.
- Experience managing deviations, CAPAs, change controls, and quality metrics.
Working Conditions:
This role is based in our Houston headquarters facility and requires a strong analytical and problem-solving mindset, excellent written and verbal communication skills, and proficiency in quality management software and tools.
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