Experience:
3-5 years of experience
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Employment Type:
Full time
Posted:
8/7/2017
Job Category:
Software Development
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QA Compliance Specialist Job
Novo Nordisk | West Lebanon, New Hampshire
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Job Description

Requisition ID 49299BR
Title QA Compliance Specialist
Job Category Quality
Job Description

This position will have responsibilities for monitoring effectiveness of the Quality System, monitoring compliance signals for QMS updates, maintain the internal audit program, and provide feedback to Management as required. This position will support the Quality Activities Plan, and lead Quality System Improvement projects as outlined by Management. This position will also participate and provide Quality input to projects involving other Quality Systems as needed, (e.g., LMS, ERP, RAM, etc.). This position will participate in organizing and supporting health authority inspections.

Relationships:

Reports to: Supervisor, Quality Assurance.

Main Job Tasks:

* Quality oversight of the EQMS; in collaboration with software vendor, leads implementation of patches, upgrades, and workflow modifications.
* This position is responsible for reporting on the effectiveness of the EQMS, and for taking action when necessary to maintain the effectiveness, including performing EQMS data trending and providing to Management Review as needed.
* Maintain the internal audit schedule, perform internal audits, and report audit trends and results as applicable.
* Assess Quality Systems efficiencies & compliance; and benchmark with other Novo Nordisk divisions to identify and incorporate best practices in managing the quality system.
* Assist Quality Management with development of the Quality Plan, and Lead Quality Improvement projects. Assist in organizing QMR.
* Perform 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.

Physical Requirements:

* Travel: 5-10%.

Knowledge, Skills and Experience:

* Bachelor's degree; preferably in a Science, Engineering or Business discipline.
* Five (5) plus years in GMP Environment, three (3) years applying and/or involved in the management and implementation of quality system processes
* Good communication skills in matrix and line management environments
* Project Management Skills
* Business Process Management, Six Sigma and/or Lean expertise desirable
* Quality Engineer certification or certified Lead Auditor desirable
* Working knowledge of Pharmaceutical Quality Management Systems and their electronic applications.
* Working knowledge of domestic and international drug regulations and standards including FDA regulations and guidance, European directives, and ICH guidelines.
* Ability to create SOPs and WIs
* Strong written, system organization, and communication skills
* Solid time management skills
* Business process management/quality process improvement experience
* Ability to analyze and summarize quality system data, and make recommendations for improvement

Department NNUSBPI Quality Assurance
Position Location US - Lebanon, NH
City West Lebanon
State/Provinces US - NH

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

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!

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.

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.

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: https://www.surveymonkey.com/r/novoaccommodation. 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.

About Novo Nordisk

Novo Nordisk A/S is a Denmark-based healthcare company. The Company provides diabetes care and is engaged in haemostasis management, growth hormone therapy and hormone replacement therapy. The Company manufactures and markets pharmaceutical products and services to patients, the medical profession and society. The Company is organized in two segments: diabetes care and biopharmaceuticals. Diabetes care includes discovery, development, manufacturing and marketing of products within the areas of insulin, glucagon-like peptide (GLP)-1 and related delivery systems, as well as oral antidiabetic products (OAD). Biopharmaceuticals includes discovery, development, manufacturing and marketing of products within the therapy areas haemostasis management, growth hormone therapy, hormone replacement therapy, inflammation therapy and other therapy areas.

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