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Supervisor - Quality Control Analytical

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. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. 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

Oversee the performance of day-to-day Quality Control activities ensuring accuracy and timeliness of testing in compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. Supply information to cross functional teams about testing timelines and related quality issues. Assist with preparation of yearly budget.

 

Relationships

Reports to: According to the organizational chart.

 

Essential Functions

  • Oversee all assays and lab procedures and ensure compliance with local, corporate, and regulatory requirements
  • Responsible for introduction of new technology, methods, equipment as needed
  • Drives completion of improvement projects in support of business and customer needs
  • Drive QC performance to meet business and customer needs
  • Ensure group training requirements are up-to-date and training is maintained to current standard
  • May represent the site in relevant process groups or be process owner for QC related programs
  • Provide coaching, mentoring and performance management of direct reports with some support. Partners with team leadership and Human Resources as appropriate
  • Provide coaching relating to leaders’ standard work and use cLEAN tools to drive continuous improvements
  • Provide coaching to ensure that deviations, change requests, laboratory investigations, and other deliverables are completed to standard, and issues are investigated to root cause in order to support site goals
  • Provide coaching and may present during regulatory inspections. Ensure requests to QC are fulfilled in a timely manner. Lead resolution of findings as assigned
  • Performs peer data and report reviews as needed.
  • Oversees the scheduling of laboratory work.
  • Technical subject matter expert on assays, techniques and industry practices relating to operational area
  • Other duties as assigned.
  • Signature Authority and responsivities:
    • QC FAM approval authority within RAM and for all work order processing activities
    • QC FAM approval authority related to training, card access and contractor management
  • PO and invoice approvals within Supervisor approval authorization limit and within established time expectations
  • 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.

 

Physical Requirements

0-10% overnight travel required. The ability to climb, balance, stoop, crouch, reach, stand, and walk. The ability to push, pull, lift, finger, and grasp. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. Lifting up to 33lbs/15kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: inside and outside conditions including temperature changes; proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals. Local and International travel: 0-10%

 

Novo Nordisk requires all employees to be fully vaccinated with a COVID-19 vaccine by December 8, 2021. Please confirm that you are fully vaccinated, are willing to be fully vaccinated prior to starting employment, or that you are seeking a reasonable accommodation to the COVID-19 vaccine mandate. 

 

Development of People

Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

 

Qualifications

  • Education and Certifications
    • BS in related field required
  • Work Experience
    • Minimum of three (3) years progressive QC experience with a Bachelor’s degree, or a Masters/PhD with a minimum one (1) years progressive QC experience
    • Experienced in a QC GMP laboratory environment.
  • Knowledge, Skills, and Abilities
    • •    Excellent analytical and writing skills are also required with the ability to author/review scientific and technical reports.
      •    Advanced knowledge in operational area (analytical or microbiology) and industry requirements/guidelines 
      •    Must be able to work independently in a team-based setting under minimal instruction/guidance
      •    Work cross functionally to maximize efficient use of resources.
      •    Troubleshoot and solve technical problems of a broad scope.
      •    Able to prioritize routine tasks and adapt to a changing environment.
      •    Excellent analytical and communication 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.