Quality Document Specialist II
POSITION OBJECTIVE: Support Quality Assurance (QA) activities. 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, including but not limited to Batch Record documents/forms, specifications, and logbooks
· Provide Final QA review, approval and release for executed Batch Records and other Doc & Data
· Maintain department readiness for internal and external audits
· Assist in the Internal Audit Program
· Provide quality system/GMP training in support of organization
· 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)
· Assist in retrieval and compilation of metric data
· 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 & Experience
· Associates degree and 2+ years’ experience in an FDA regulated environment. Background and experience may be considered in lieu of degree.
· Bachelors degree a plus.
Required Skills & Abilities:
· Knowledge of GMPs
· Knowledge & experience with use of current software (e.g., Word, Excel, PowerPoint, etc.)
· Knowledge and experience with use of electronic quality management systems preferred
· Office based position, remote work may be authorized for certain approved tasks
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.