Deviation Investigator-Writer II (Onsite)

Facility:  Quality
Location: 

West Lebanon, NH, US

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
  • 36 Paid days off including vacation, sick days & 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

  • 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 processing steps
  • Manage multiple deviation investigations simultaneously
  • Support CAPAs, Change Controls, Deviations, Out of Specifications and Manufacturing Investigation records
  • Provide follow-up and scheduling to ensure the batch release process is not impacted by outstanding deviations
  • Ensure investigations will comply with internal NN requirements and are compliant with cGMP regulations
  • Update SOPs or other official documents as required
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
  • Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
  • Support other quality compliance and implementation projects, as assigned
  • Other Duties as assigned

 

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.

 

Qualifications

  • Education 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 environment
    • Experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry
    • Experience 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 Reduction
    • Technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry. Experience with deviation or investigation management systems
    • Ability 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 report
    • Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment
    • Ability to evaluate data and make recommendations based on data analysis
    • Must be familiar with health authority (FDA) requirements
    • Ability to work in a fast-paced environment with the capability to prioritize effectively to meet timelines
    • Facilitation and coaching skills
    • Strong technical writing skills
    • Familiar with Lean Six Sigma methodologies and proven analytical/problem solving capabilities, analysis of complex problems through critical analytical thinking
    • Previous experience in writing investigations for atypical events in a manufacturing environment
    • Demonstrated ability of meeting goals/timelines/organizational skills
    • Demonstrated ability to work both independently and as a part of a cross-functional team
    • Good organizational, communication, and interpersonal skills

 

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.