Manufacturing Investigator / Deviation Writer at Softworld Inc

Job Title: 81843 - Manufacturing Investigator / Deviation Writer

Job Location: Canton MA 02021

Job Description:

Our 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.