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Quality Control Environmental Monitoring Associate I

Employer
Novo Nordisk
Location
West Lebanon, NH
Start date
Nov 15, 2023

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Discipline
Clinical, Clinical Testing/Monitoring, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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
  • 34 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

This position has primary responsibility to support operations in the Quality Control (QC) Department. This position will organize testing and maintain standards for the environmental monitoring program residing within QC.  It has primary responsibility to coordinate, author and report issuance for the Environmental Monitoring (EM) program.

 

Relationships

Reports to: According to the organizational chart.

Number of subordinates with direct/indirect referral: n/a.

 

Essential Functions

  • Author’s protocol and reports to support EM program qualification activities
  • Supports the project management of the EM program
  • Partners with external EM program resources
  • Liaison between internal Manufacturing and QC Microbiology for scheduling and coordination of activities as needed
  • Coordinates data flow for both routine and study activities
  • Complete understanding/application of quality systems with the ability to manage Change Controls
  • Supports data review and trending and issuing of monthly trend reports
  • Issues and tracks EM deviations and able to assist in root cause analysis
  • Supports CAPAs with assisting in corrective action implementation
  • Supports Health Authority inspections
  • 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 Code of Conduct values in all activities and interactions with others
  •  

    Physical Requirements

    0-10% overnight travel required. The ability to climb, balance, stoop, kneel, crouch, crawl, reach, stand, and walk. The ability to push, pull, lift, finger, feel, 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. The worker is required to function in narrow aisles or passageways. 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, fumes, odors, dust, mists, gases, or poor ventilation.

     

    Qualifications

    • Education and Certifications:
    • Bachelor’s degree or equivalent in microbiology, biological sciences or related field with 3+ years of experience
  • Work Experience:
  • Familiarity with regulatory requirements for environmental monitoring of cleanroom areas
  • Knowledge, Skills, and Abilities:
  • Requires full understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines
  • Preferred small project management experience. Ability to manage/lead projects and coordinate activities between both internal and external groups
  • Has ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniques
  • Excellent organizational 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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Telephone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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