Experience:
5+ years of experience
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Employment Type:
Full time
Posted:
7/13/2017
Job Category:
Engineering
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Supplier Quality Area Specialist Job
Novo Nordisk | Clayton, North Carolina
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Job Description

Requisition ID 48945BR
Title Supplier Quality Area Specialist
Job Category Quality
Job Description Position Purpose:
* Oversees & coordinates daily processes & activities in relation to Supplier management (direct spend, indirect spend & process aids) to assure objectives are met.
* Assist departments in corrective actions & quality improvement initiatives regarding Suppliers.

Accountabilities:
* NNPII (DFP) Audit Client - Requests & coordinates audits in the Supplier audit program & requests changes of audits in the program.
* Provides QA oversight for new Supplier/materials, maintenance of the Supplier program & discontinuation of supplier/materials (Direct Spend, In-spend & Process Aids).
* Updating & approving the local Approved Supplier list (ASL), Quality Agreements (QA) & Quality Supplier Agreements (QSAs).
* Annual review of corporate ASL for NNPII (DFP) suppliers/materials.
* Assist stakeholders on bringing new suppliers/materials on-board.
* Coordinate audit supplier responses with stakeholders utilizing the novoGloW system.
* Interface with suppliers in regards to Quality issues/concerns.
* Participate in project teams as the Supplier management compliance resource to ensure all requirements are met.
* Facilitate sharing of regulatory & compliance expectations with stakeholders to assure compliance with company procedures, policies & objectives.
* Review/approve complex audit findings, CRs, SOPs, trend & report data for CAPA, QMRs & APR reports.
* Function as back-up for the Audit & Inspections process.
* Perform other duties as assigned.

Education: BA/BS degree in Life Sciences, Engineering, or related field or equivalent combination of education & experience.

Experience:
* 6+ years of QA &/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
* Demonstrated expertise in regulations & quality systems (e.g. NC/CAPA, Change Control, Audits, Supplier Management & Project Management)

Technical/Process/Functional Knowledge:
* Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing, & process utilities.
* Knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in aseptic manufacturing.
* Excellent written & verbal communication skills.
* Basic computer skills in MS Office, MS Project, PowerPoint, etc.
* Auditing experience with certification preferred.
* Experience coordinating GMP Audit & Inspections.
* Understanding of Six Sigma & LEAN tools.

Organization/Planning:
* Controls time (prioritizing, adapting changes to plan, reducing time wasters, etc.) in complicated multi-project situations, on a short & long-term basis.
* Adjusts priorities & goals in accordance with business needs.
* Maintains high performance standards under repetitive time pressure.

Physical & Other Requirements:
* Must be willing to work hours necessary to support a 24/7 operation.
* Also must be able to travel internationally on occasion.
* Ability to travel overseas - estimated once per year.

Department Quality Systems Management and Support
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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