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Quality Assurance Area Specialist II
West Lebanon, NH 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 Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance Review and assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and deviation issues Assists in performing and reporting internal and vendor audits as scheduled Participate in Regulatory 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 Way and 10 Essentials in all activities and interactions with others Other duties as assigned Physical Requirements 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 occasionally or constantly to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing. Local and International travel: 0-5%. Qualifications Education and Certifications: Bachelor’s Degree (or equivalent) required, a scientific discipline preferred Work Experience: A minimum of three (3) years of GMP-related experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors. KEY Excellent written and verbal communication and negotiating skills are required Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken Normally receives little to no instructions for routine work, and general instructions for new assignments Strong planning and organization skills, with flexibility for changes in work priorities 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 **MEMBERS ONLY**SIGN UP NOW***. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. |
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