Deviation Investigator-Writer II (Onsite)
Novo Nordisk - West Lebanon, New Hampshire, us, 03784Work at Novo Nordisk
Overview
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Overview
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 assignedQualificationsEducation 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 preferred
Knowledge, 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 RequirementsProlonged 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.