Quality Assurance Document Coordinator Lead

Buffalo/Dunkirk, NY, United States Full Time

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POSITION OBJECTIVE:         Implement and support Quality Assurance activities at the Athenex Inc. Buffalo and Dunkirk, NY facilities. Activities to include issuance and review of regulated documents, change management, training administration, and process review for compliance with current Good Manufacturing Practices.

This position will be located in our Buffalo, NY office for the first 6 to 12 months and will then transition to our Dunkirk, NY facility.

Essential Job Functions/Responsibilities

·       Oversee transfer of documents and training systems to the Dunkirk Site

·       Help to refine and continuously improve documents and training systems to meet site needs

·       Position will initially be an individual contributor, but will lead into supervisory role as facility build-out progresses

·       Maintains training status and routine review of training compliance

·       Process SOP updates and review content to assist QA management approval

·       Manages validation documentation

·       Management of Quality Events (CAPA, Change Control, Complaints, etc.)

·       Provide compliance review of general quality system elements (e.g., change control, work orders, working documents)

·       Archives batch records other controlled documents (organizes and archives records, both paper and electronic)

·       Good communication skills, works closely with manufacturing personnel to meet the needs of operations

·       Follow good manufacturing and documentation practices


Required Education & Qualifications

·       Knowledge of GMPs, documentation processes\requirements

·       Associates Degree from accredited college/university preferred

·       Experience in a regulated environment preferred

·  Knowledge of current software (e.g., Word) and electronic systems

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.

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