Manager of QA Compliance overseeing Quality Agreements in biotech firm BridgeBio Pharma. Collaborating cross - functionally for compliance and inspection readiness in FDA - regulated environments.
About the role
- Quality Assurance Specialist II ensuring compliance with regulatory requirements and industry standards for health-related products. Develops quality assurance activities and supports audits and investigations.
Responsibilities
- Develops, implements, and conducts the spectrum of quality assurance activities for health-related products.
- Ensures compliance with applicable regulatory requirements and industry standards.
- Supports audits and investigations and reviews/analyzes data and documentation.
- Provides updates to and maintains the quality management system.
- Performs administrative duties of purchasing supplies and laboratory maintenance.
Requirements
- Bachelor's Degree or its International Equivalent in Knowledge/Information Services, Communications, Education, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.
- 3 - 5 years of quality assurance, laboratory, or related experience.
- Non-governmental organization (NGO) experience preferred.
- Strong knowledge of software programs used to perform data analysis and reviews.
- Must be able to read, write and speak fluent English.
Benefits
- FHI 360 contributes 7% of monthly base pay to a money purchase pension plan account.
- 18 days of paid vacation per year.
- 12 sick days per year.
- 11 holidays per year.
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