QC Associate

1 month ago

Lebanon, Oregon, 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 positions36 Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuaranteed 8% 401K contribution plus individual company match option12 weeks Paid Parental LeaveFree 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. RelationshipsReports to: Quality Control ManagerNumber of subordinates with direct/indirect referral: no direct reports Essential FunctionsLiaison between Manufacturing and QC for the coordination of process/equipment improvements, sample testing and data trending/analysisReview of completed QC documentationAbility to assist with training to support on the QC equipment/processesRevise documentation (SOP, forms, reports, notebooks) associated with the testing of in-process/product samples, requiring some directionIncorporate pre-planned process improvements and cost reduction projects into QCAbility to take on multi-disciplined projects, with minimal supervisionFunctional understanding/application of quality systems with the ability to manage Change ControlsSupport deviation and CAPA investigations and corrective actionsSupport of Health Authority inspectionsSupport area equipment validations in accordance with procedures requiring some directionPossesses technical and systems knowledge and is able to research information outside of knowledge baseHas ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniquesOther duties as assignedPerforms 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 others QualificationsEducation 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 experienceKnowledge, Skills, and Abilities:Requires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelinesAbility 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. 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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