QA Investigative Writer, Change Control - (Buffalo, NY)

QA Investigative Writer, Change Control Clarence, NY, United States Full time Apply for position now POSITION OBJECTIVE: Support Quality urance (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. This position will also be responsible for overseeing the change control process. Essential Job Functions/Responsibilities Generation of controlled documents in support of APS operations, including but not limited to specifications, protocols and standard operating procedures. Oversee the change control process Supports investigative writing for the manufacturing facility Thoroughly Investigate process deviations and customer complaints Perform root cause analysis and identify corrective / preventative actions to address quality deficiencies.