Posted to MedZilla on 3/17/2018

Novo Nordisk

US-NC, Process Area Specialist - QC Job 461399200A0-MZ


Requisition ID 54602BR
Title Process Area Specialist - QC
Job Category Manufacturing
Job Description Position Purpose:
* Maintaining & making improvements to the Production Environmental Monitoring (PEMS) system including performing changes related to the Master Data.
* Perform investigations of EM Excursions.
* Completion of PEMS batch reports.

* Responsible for developing & performing training on aseptic concepts.
* Responsible for identifying aseptic process needs & improvement opportunities.
* Responsible for performing root cause analysis investigations for environmental excursions through use of SPS tools.
* Responsible for ensuring timely completion of EM investigations.
* Responsible for performing process confirmations to ensure compliance and process improvements.
* Responsible for generating PEMS reports to support batch release activities.
* Responsible for training on PEMS, aseptic concepts & EM sampling techniques.
* Responsible for ensuring department documents are current & standardized.
* Perform other duties as required.

Education: BS/BA in life sciences, engineering, computer science, or related field or equivalent combination of education & experience.

* 3+ years of aseptic manufacturing experience in a pharmaceutical environment.
* Environmental Monitoring experience preferred.
* Strong working knowledge of database management systems.

Technical/Process/Functional Knowledge:
* Ability to read, write & understand standard operating procedures with attention to high-level concepts.
* Computer literacy.
* Ability to drive continuous improvements via Lean tools & Six Sigma methodologies.
* Knowledge of Aseptic conduct and behaviors in a pharmaceutical environment.

Organization/Planning: Proven expertise in planning/organizing, managing execution, checking results & revising plans.

Physical & Other Requirements:
* Ability to attain clean room gowning certification.
* Ability to work with hazardous materials including sanitants.
* Ability to work near operating equipment.
* Ability to travel internationally.
* Ability to work hours necessary to support production.

Department QC Environmental Monitoring Process
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Job/Position Country US

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: 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.

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