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

Requisition ID 49429BR
Title Process Area Specialist - QC
Job Category Quality
Job Description Position Purpose:
* Responsible for maintaining and making improvements to the Production Environmental Monitoring (PEMS) system and assist with aseptic and environmental monitoring programs and investigations.
* Responsible for initiating, coordinating and writing EM excursion investigations.
* Responsible for EM trending.
* Responsible for aseptic process, activities and training in order to achieve perfect execution of Aseptic Operations.


* Responsible for developing and leading training on aseptic concepts.
* Responsible for identifying aseptic process needs and improvement opportunities.
* Responsible for coaching and leading investigations for process-related issues.
* Responsible for performing EM trending activities.
* Responsible for generating PEMS reports to support batch release activities.
* Responsible for training on PEMS, aseptic concepts and EM sampling techniques.
* Responsible for serving as coach and mentor for aseptic techniques to process personnel on the shop floor.
* Responsible for coaching and leading, initiating, coordinating and writing investigations for environmental excursions.
* Responsible for assisting with gowning certification.
* Responsible for ensuring department documents are current and standardized.
* Perform other duties as required.

Required Education:

Bachelor's Degree in Life Sciences, Engineering, Computer Science, or related field or equivalent combination of education and experience


3+ years of aseptic manufacturing experience in a pharmaceutical environment; strong working knowledge of database management systems

Technical/Process/Functional Knowledge:

Ability to read, write and understand complicated product documentation and standard operating procedures with attention to high-level concepts and computer literacy. Ability to drive continuous improvements via Lean tools and Six Sigma methodologies.


Proven expertise in planning/organizing, managing execution, checking results, revising plans.

Physical & Other Requirements:
* Ability to attain clean room gowning certification.
* Ability to work near operating equipment.
* Ability to work hours necessary to support production.

Department QC Environmental Monitoring Process
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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