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Qc Associate

3 months ago

West Lebanon, 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 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**

This position has primary responsibility to support operations for Quality Control at our biologics manufacturing facility. Assists in coordination and execution of process and equipment improvement programs, creates technical reports, reviews completed quality records, generates quality comment and deviation responses and has ability to provide training support. Prior experience as a Technical Writer, or peforming Technical Writing, is preferred for this position. This role will support our QC teams under the direction of the QC Manager.

**Relationships**
- Reports to: Quality Control Manager
- Number of subordinates with direct/indirect referral: no direct reports

**Essential Functions**
- Liaison between Manufacturing and QC for the coordination of process/equipment improvements, sample testing and data trending/analysis
- Review of completed QC documentation
- Ability to assist with training to support on the QC equipment/processes
- Revise documentation (SOP, forms, reports, notebooks) associated with the testing of in-process/product samples, requiring some direction
- Incorporate pre-planned process improvements and cost reduction projects into QC
- Ability to take on multi-disciplined projects, with mínimal supervision
- Support deviation and CAPA investigations and corrective actions
- Support of Health Authority inspections
- Support area equipment validations in accordance with procedures requiring some direction
- Possesses technical and systems knowledge and is able to research information outside of knowledge base
- Has ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniques
- Other duties as assigned
- 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

**Qualifications**
- Education and Certifications:

- High School diploma or equivalent with a minimum of six (6) years relevant manufacturing experience or a Bachelor’s degree or equivalent in a science or engineering discipline with three (3) or more years of experience
- Knowledge, Skills, and Abilities:

- Requires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines
- Ability to understand and execute established written instructions is essential

**Physical Requirements**

0-10% overnight travel required. The ability to climb, balance, kneel, 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: noise, 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.

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.