Deviation Investigator-Writer II

1 month ago

Lebanon, Oregon, United States Novo Nordisk Full time

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 positions36 Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuaranteed 8% 401K contribution plus individual company match option12 weeks Paid Parental LeaveFree 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. This role is a full-time onsite based role at our West Lebanon, NH site. Relocation assistance is available for selected candidate. Relationships Reports to: Manager, Compliance & Investigations Essential FunctionsThe investigation owner will lead the investigation of deviations that occur in operations and perform technical writing of investigationsAuthor and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reportsProvides 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 teamsLead cross-functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations on batch dispositionFacilitates 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 environmentTrack and identify Quality System and root cause trends and identify opportunities for operational improvementsCoach and drive root cause analysis (RCA) conducts personnel interviews to determine the root cause of the deviation. Utilize systematic problem-solving tools to resolve deviationsIdentify and initiate corrective and preventive actions for deviations. Ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issuesWork without direct guidance and minimal oversight to get results, meet timelines, and improve processesEffectively communicate with peers and colleagues regarding the status of investigations and offer recommendations based on investigation outcomesProvide oversight for technically challenging investigationsDevelops 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 processing stepsManage multiple deviation investigations simultaneouslySupport CAPAs, Change Controls, Deviations, Out of Specifications and Manufacturing Investigation recordsProvide follow-up and scheduling to ensure the batch release process is not impacted by outstanding deviationsEnsure investigations will comply with internal NN requirements and are compliant with cGMP regulationsUpdate SOPs or other official documents as requiredPerforms all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codesIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with othersSupport other quality compliance and implementation projects, as assignedOther Duties as assigned QualificationsEducation and Certifications:B.S./M.S. degree in related engineering/scientific field.Work Experience:Minimum 3 years of experience conducting deviation investigations in a cGMP pharmaceutical manufacturing environmentExperience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industryExperience in API Manufacturing preferredKnowledge, Skills, and Abilities:Proficient in the use of problem-solving tools such as: A3, 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error ReductionTechnical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry. Experience with deviation or investigation management systemsAbility to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation reportExperienced in troubleshooting, investigation, and root-cause analysis in a cGMP environmentAbility to evaluate data and make recommendations based on data analysisMust be familiar with health authority (FDA) requirementsAbility to work in a fast-paced environment with the capability to prioritize effectively to meet timelinesFacilitation and coaching skillsStrong technical writing skillsFamiliar with Lean Six Sigma methodologies and proven analytical/problem solving capabilities, analysis of complex problems through critical analytical thinkingPrevious experience in writing investigations for atypical events in a manufacturing environmentDemonstrated ability of meeting goals/timelines/organizational skillsDemonstrated ability to work both independently and as a part of a cross-functional teamGood organizational, communication, and interpersonal skills Physical Requirements Prolonged periods of sitting or standing at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Ability to gowning and work in clean room areas for investigations. Off-shift work may be required. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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