Quality Assurance Associate
The GxP QA is responsible for overseeing end- to-end quality operational activities and programs related to GMP product manufacturing, while supporting GLP and GCP quality activities. He/She develops, interprets, and implements quality policies, authors procedures, and supports regulatory compliance inspections. Manages QA operational activities that support GMP manufacturing, testing and release of finished biological products under FDA regulations, applicable International Regulations, ICH standards, and Inhibrx Inc. procedures. Strong knowledge of drug substance development, drug product manufacturing process design, and quality systems.
Essential Functions of the job:
- Supports product development, management, QA program, systems, policies, procedures and controls to ensure that Inhibrx products conform to established standards and regulatory agency requirements.
- Qualification and oversight of CMOs.
- Work with Regulatory department for late stage Product development through BLA.
- Work with CMO and internal staff to ensure the end-to-end manufacturing processes remain in a compliant state, and final product meets all required standards and specifications.
- Work with Regulatory and CMC to establish Process Performance Qualification for Products.
- Co-Lead Technology Transfer of CMC processes to and from CMOs.
- Co-Lead the transfer of analytical methods to contracted testing laboratories.
- Work with regulatory in providing technical responses to FDA inquiries.
- Manage documentation, reporting and closure of product related compliance issues.
- Author Standard Operating Procedures related to functional and department.
- Review relevant GMP documents for compliance to company SOPs, quality systems and regulatory requirements.
- Oversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion.
- Provide intradepartmental QA support, as needed, in the areas of GLP and GCP. compliance.
Core Competencies, Knowledge and Skill Requirements
- Practical experience in product and process development
- Practical experience in technology transfer of manufacturing process and analytical methods
- Practical experience in establishing process performance qualification for biologics
- Practical Experience in the Drug Product late stage through BLA
- Practical Experience in Biologics Manufacturing and Process Validation
- Technical Knowledge and experience in DS Manufacturing
- Technical knowledge and Experience in Sterile Manufacturing
- Practical experience in providing technical responses to FDA inquires
- Working knowledge of GMP regulations and experience with regulatory compliance inspections
- Working Knowledge and experience with 21CFR210, 21CFR211, ICHQ7 as well as international regulations
- Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems
- Ability to effectively lead teams and manage staff
- Open to gaining knowledge and experience in other area of QA compliance (e.g., GLP, GCP)
Communication & Interpersonal Skills
- Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail
- Effective email communication skills with internal and external collaborators