Manufacturing Investigator / Deviation Writer

Job Title 81843 - Manufacturing Investigator / Deviation WriterJob Location Canton MA 02021Job DescriptionOur client is seeking a deviation writer to perform manufacturing investigative writing and technical writing, including but not limited to change controls, protocols, reports, and/or standard operating procedures/manufacturing batch records. ESSENTIAL JOB FUNCTIONS:Independently responsible for the investigation of process deviations, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies.Ability to work with others and gather internal and external sources to evaluate the impact of the deviation on previously manufactured products, as well as the risk to future operations. Prepares and analyzes historical data and uses methodical root-cause analysis tools to determine and effectively communicate root causes. Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources to perform a risk assessment of the impact each process deviation has on the product, process, and patient health and safety.??? Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, impact to product or patient/operator safety. Provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.

Created: 2025-01-28