3-5 years of experience
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Employment Type:
Full time
Job Category:
Quality Improvement Area Specialist Job
Novo Nordisk | Clayton, North Carolina
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Job Description

Requisition ID 49284BR
Title Quality Improvement Area Specialist
Job Category Quality
Job Description Position Purpose:

The purpose of this position is to lead and improve process quality on shift in addition to improving quality within department by solving problems, sharing solutions, and ideas with other shifts.

* Responsible for investigation and solution of quality problems on shift - non-conformities and unscheduled events
* Ensure Badge Production Record (BPR) accurateness and timely approval
* Work with process team to find preventive actions to eliminate re-occurrence of quality problems
* Ensure compliance with training programs (IsoTrain/Eduneering) and confirm process
* Execute process confirmation of standards utilized on shift and work with team members to improve the quality and compliance
* Actively communicate corrective actions from investigations and confirm with all team members
* Ensure compliance with one Diabetes Finished Products (DFP) standards on shift
* Perform periodic assessment of compliance (audit readiness) of shift personnel
* Perform other duties as required

BA/BS degree or equivalent industry experience


Five (5) years of manufacturing experience in a pharmaceutical environment
Two (2) years of Aseptic Processing experience (Aseptic Processing Department only)

Technical/Process/Functional Knowledge:
* Experience using Lean/Six Sigma methodologies and achieving sustainable process improvements
* Knowledge of US, EU regulations and guidelines, and application of GMP's
* Demonstrates knowledge of adult learning methodologies and able to use multiple methods to train and coach others
* Excellent written communication skills, investigative writing, and computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP and novoLIMS)
* Demonstrated experience in practical problem solving and process improvement methods
* Ability to manage multiple tasks/deadlines and prioritize properly based on process needs
* Demonstrated effectiveness in systematic follow-up
Physical Requirements:
* Ability to work 12 hour shifts or longer, day or night
* Ability to attain Clean Room Gowning certification and work with hazardous materials including sanitants. (Aseptic Production)
Other Requirements:
* Ability to work hours necessary to support shift production
* Ability to travel internationally
* Ability to achieve Core Gown certification (Aseptic Production)

Department AP - Form/W&S/Insp. Team A (Days)
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC

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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