As Quality Assurance Document Specialist, you will support Quality Assurance (QA) activities at the Athenex Pharma Solutions Clarence, NY facility. Activities to include issuance and review of regulated documents, ensure processes and products are in compliance with current Good Manufacturing Practices and 21CFR 210/211, and provide QA support for internal Quality Systems.
Essential Job Functions/Responsibilities
- Generation of controlled documents in support of APS operations, including but not limited to Batch Record documents/forms, specifications and logbooks
- Maintain department readiness for internal and external audits
- Maintain training requirements and records within electronic systems
- Process and support Doc & Data creation and updates
- Provide compliance review of general quality system elements (e.g., change control, work orders, working documents, etc.)
- Maintain current and archived versions of controlled documents/records (paper and electronic)
- Build and maintain collaborative working relationships within the organization
- Effective communication throughout all facets of the organization
- Follow and solicit good manufacturing and documentation practices
- Support QA compliance activities as needed
- Support Quality Management System continual improvement initiatives
- Other activities/tasks as dictated by departmental and organizational needs
Required Education & Qualifications
- Minimum of a High School diploma or equivalent; Associates Degree preferred
- Knowledge of Good Manufacturing Practices (GMPs)
- Experience in a regulated environment, Pharma or other medical preferred
- Knowledge & experience with use of current software (e.g., Word, Excel, PowerPoint, etc.)
- Knowledge and experience with use of electronic quality management systems preferred
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.