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Quality Assurance Area Specialist III
Location:
West Lebanon, NH
Description:
Site New Hampshire, located in West Lebanon, is where Novo Nordisks 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. Its not your average production site its 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. Were 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 This position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the manufacturing floor. Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and proceduresReleases product based on Quality Assurance record review and approval by QA ManagerPerforms regular internal audits of NNUSBPI facilities as a lead auditorWorks closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issuesPerforms vendor audits as scheduledReviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending. Possess signature authority for deviation closureReviews and approves Validation DocumentationReviews and assesses Corrective and Preventive Action ReportsParticipates in Regulatory InspectionsOther 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 Physical Requirements Local and International travel: 0-5%. The ability to stand, crouch, walk, and lift. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, verification and analyzing. Qualifications Education and Certifications:Bachelors Degree (or equivalent) required, a scientific discipline preferredWork Experience:A minimum of five (5) years of GMP-related experience in a pharmaceutical or biotechnology company, with three (3) years of direct QA experienceExperience in a licensed drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferredAs applicable, experience with Quality Assurance oversight and support for all phases of Clinical and Production documentation and processesKnowledge, Skills, and Abilities:Excellent written and verbal communication and negotiating skills are requiredStrong planning and organization skills, with flexibility for changes in work prioritiesMust be able to exercise judgment within defined practices and policies to determine appropriate action to be takenNormally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutionsAbility to work on complex Quality projects where analysis of data requires evaluation of identifiable factors 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, were 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-XXXX. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Posted:
October 25 on Jobvertise
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More About this Listing: Quality Assurance Area Specialist III
Quality Assurance Area Specialist III is a Quality Assurance QA Job located in West Lebanon NH. Find other listings like Quality Assurance Area Specialist III by searching Oodle for Quality Assurance QA Jobs.
Quality Assurance Area Specialist III is a Quality Assurance QA Job located in West Lebanon NH. Find other listings like Quality Assurance Area Specialist III by searching Oodle for Quality Assurance QA Jobs.