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

Requisition ID 49396BR
Title QA Area Specialist API
Job Category Quality
Job Description Your Groundbreaking Journey

At Novo Nordisk, we want to make a difference. For more than 90 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.

To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.

Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

Position Purpose:
Main duties include review & approval of Validation Life Cycle documentation (requirements, planning, protocols & reports). Other duties include review/approval of NCs, Change Requests, SOPs, Training Material, Laboratory Investigations, Trend Reports, Supplier Management, Self Audits (in conjunction with LoB), QA presence & process confirmation on shop floor, & improvement of Quality processes.


* Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs.
* Review & approve change control requests.
* Review and Approve of validation life documentation including requirements, planning, protocols, test plans, reports and risk assessments.
* Participate in project teams as the compliance resource.
* Provide guidance to departments regarding quality-related activities.
* Support root-cause analysis & review/approve cross-functional investigations.
* Participate in process confirmations & Go Look Sees.
* Participate in knowledge & experience sharing with other QA personnel to assure compliance with company procedures, policies & objectives.
* Evaluate trend & report data for QMRs & APR reports.
* Perform other duties as assigned.
BA/BS degree in Life Sciences, Engineering, or related field.

* 4 years of QA &/or Validation related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
* Demonstrated expertise in validation, regulations & quality management systems (e.g., Validation, Product disposition, NC/CAPA, Change Control, Audits, Supplier Management, and Project Management, etc.).
* Familiarity with local processes & quality management systems.
Technical/Process/Functional Knowledge:
* Demonstrated knowledge of critical controls & input/output requirements for API processes.
* Knowledge of Quality, Business Support, QC &/or API Production processes.
* Knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in pharmaceutical manufacturing.
* Excellent written & verbal communication skills.
* Basic computer skills in MS Office, Project, PowerPoint, Excel, etc.
* Internal auditing experience with certification preferred.
* Experience in the use of Six Sigma & LEAN tools.
* Good stakeholder management & change management skills.
* Strong in setting direction & describing framework.
* Solid structural & follow up skills.
Physical & Other Requirements:
* Ability to work in & around an active construction site.
* Ability to move throughout the facility in the performance of duties in proximity of process equipment & areas.
* Ability to work hours necessary & according to process needs.
* Must be able to travel internationally.

Department DAPI US - QA Validation
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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