Requisition ID 44857BR<br/>Title QA Area Specialist<br/>Job Category Quality<br/>Job Description<br/>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 assist in and help lead the internal audit program, make vendor assessment recommendations, and be a QA presence on the manufacturing floor. This position will have signature authority to close non-conformities and CAPA.<br/><br/>Relationships:<br/><br/>Reports to: Sr. Manager, Quality Assurance.<br/><br/>Main Job Tasks:<br/><br/>* Reviews all manufacturing and support records to certify compliance with specifications and procedures.<br/>* Releases product based on Quality Assurance record review and approval by QA Manager.<br/>* Performs regular internal audits of NNUSBPI facilities as a lead auditor.<br/>* Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues.<br/>* Performs vendor audits as scheduled.<br/>* Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending. Possess signature authority for deviation closure.<br/>* Reviews and approves Validation / Technical Reports.<br/>* Reviews and assesses Corrective and Preventive Action Reports.<br/>* Participates in Regulatory Inspections.<br/>* Other duties as assigned.<br/>* Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.<br/>* Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.<br/><br/>Physical Requirements:<br/><br/>* Travel: 5-10%.<br/><br/>Knowledge, Skills and Experience:<br/><br/>* Bachelor’s Degree (or equivalent) required, a scientific discipline preferred<br/>* A minimum of five (5) years of GMP-related experience in a pharmaceutical or biotechnology company, with three (3) years of direct QA experience.<br/>* Experience in a licensed drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred.<br/>* As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and Production documentation and processes.<br/>* Excellent written and verbal communication and negotiating skills are required.<br/>* Strong planning and organization skills, with flexibility for changes in work priorities.<br/>* Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken.<br/>* Normally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutions.<br/>* Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors.<br/><br/>Department NNUSBPI - QUALITY ASSURANCE<br/>Position Location US - Lebanon, NH<br/>City West Lebanon<br/>State/Provinces US - NH
<br/><br/>At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
<br/><br/>With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
<br/><br/><p class="eeo_desc">Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.<br/><br/>
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.<br/><br/>
If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: <a href="https://www.surveymonkey.com/r/novoaccommodation" target="_blank" title="Accomodation Survey">https://www.surveymonkey.com/r/novoaccommodation</a>. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.</p>
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