Quality Assurance Investigative Writer

Clarence, NY, United States Full Time

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POSITION OBJECTIVE:         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 specifications, protocols and standard operating procedures.    

·       Thoroughly Investigate process deviations and customer complaints

·       Perform root cause analysis and identify corrective / preventative actions to address quality deficiencies.

·       Track and identify trends related to quality deficiencies captured during the investigative process being proactive alerting management to concerns

·       Recommend and assist in corrective measures to prevent repeat occurrences of quality issues.

·       Evaluate potential impact a deviation or investigation may have on previous product and alert management of quality concerns 

·       Maintain department readiness for internal and external audits

·       Collect information from all necessary internal and external sources to assist in a thorough investigation

·       Provide technical oversight and assistance to ensure corrective actions and preventative actions are complete and timely.

·       Revise and update SOP’s and procedures as a result of investigations / corrective actions 

·       Ensure that deadlines supporting investigations are met and extensions are requested in a timely manner if needed.   

·       Track quality system/GMP training to minimize / prevent lapse in compliance for employees at the site.

·       Provide assistance to area management to aid in problem solving for critical issues.

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

·       Assist in retrieval and compilation of metric data for the investigative process capturing turnaround times and effectiveness of associated CAPA’s  

·       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

·       Bachelor’s degree (Biology, Chemistry or related science)  

·       2 – 3 years related experience including a working knowledge of GMPs

·       Excellent interpersonal and communication skills both verbal and written

·       Experience in a regulated environment, Pharma or other medical preferred

·       Knowledge & experience with use of current software MSOffice (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.

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