This listing was posted on Tip Top Job.
Deviation Investigator:Writer II (Onsite)
Location:
West Lebanon, NH
Description:
About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life:saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting:edge medications. What we offer you: :Leading pay and annual performance bonus for all positions:36Paid days off including vacation, sick days and company holidays:Health Insurance, Dental Insurance, Vision Insurance:Guaranteed 8 401K contribution plus individual company match option:12 weeks Paid Parental Leave:Free access to Novo Nordisk:marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential? The Position The Deviation Investigator:Writer is responsible for investigating and writing of deviations to the manufacturing process and other operational problems as assigned. This position is responsible for leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator:Writer will be responsible for initiating investigations and writing deviations in numerous cGMP areas for API manufacturing. The role will be responsible for operating cross:functionally, collecting necessary data and information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the Deviation Response Team team and a champion for quality priority principles and compliance within the organization. Relationships Reports to: According to the organizational chart. Essential Functions stylemargin:bottom:11.0px::The investigation owner will lead the investigation of deviations that occur in operations and perform technical writing of investigations:Author and manage the investigations to meet key timing commitments, with well:investigated and well:documented deviation reports:Provides consistent direction and ensures timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Operations and Quality teams:Lead cross:functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations on batch disposition:Facilitates and collaborates with cross functional groups like manufacturing, QC, Facilities, MSAT, process engineering and other departments liable for GMP activities, to support investigation and resolution of deviations and other compliance discrepancies. Promotes a respectful and collaborative work environment:Track and identify Quality System and root cause trends and identify opportunities for operational improvements:Coach and drive root cause analysis (RCA) conducts personnel interviews to determine the root cause of the deviation. Utilize systematic problem:solving tools to resolve deviations:Identify and initiate corrective and preventive actions for deviations. Ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues:Work without direct guidance and minimal oversight to get results, meet timelines, and improve processes:Effectively communicate with peers and colleagues regarding the status of investigations and offer recommendations based on investigation outcomes:Provide oversight for technically challenging investigations:Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate proc
Posted:
May 17 on Tip Top Job
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More About this Listing: Deviation Investigator:Writer II (Onsite)
Deviation Investigator:Writer II (Onsite) is a Media, Journalism & Newspaper Jobs Writer Job located in West Lebanon NH. Find other listings like Deviation Investigator:Writer II (Onsite) by searching Oodle for Media, Journalism & Newspaper Jobs Writer Jobs.
Deviation Investigator:Writer II (Onsite) is a Media, Journalism & Newspaper Jobs Writer Job located in West Lebanon NH. Find other listings like Deviation Investigator:Writer II (Onsite) by searching Oodle for Media, Journalism & Newspaper Jobs Writer Jobs.