Supervisor, Environmental Monitoring Process Job:
Novo Nordisk

53352BR
Novo Nordisk
Clayton North Carolina
Pharmaceutical
Description
Requisition ID 53352BR
Title Supervisor, Environmental Monitoring Process
Job Category Quality
Job Description Position Purpose:
Responsible for supervising QC Environmental Monitoring personnel including, Senior Specialists, Specialists & Coordinators. Ensures that non-conformity & environmental excursion investigations are thorough, PEMS batch reports are accurate & complete & trend reports are accurate & complete. Ensures that all required EM Process deliverables are in compliance with corporate regulatory requirements & are timely to support business KPIs. Oversees projects to increase regulatory compliance &/or business efficiency.

Accountabilities:
* Leading team in successful execution of the testing process
* Coordinating with the responsible manager & other teams on workload issues & priorities
* Weekly planning to ensure resources are in place to execute the cycle plan
* Ensure tracking & reporting of KPI’s
* Communication with customer
* Responsible for ensuring department documents are current & standardized.
* Support training & development of EM Coordinators & QC Process Area Specialists
* Ensure data integrity of PEMs system & timely reporting of PEMs data for batch release
* Responsible for Environmental Monitoring process (EM) to include ensuring effective investigations & corrective & preventative actions
* Perform other duties as required.
Required Education:
Bachelor’s Degree in Life Sciences, Engineering, or related field or equivalent combination of education & experience.

Experience:
5+ years of aseptic manufacturing experience in a pharmaceutical environment; strong working knowledge of database management systems. Leadership experience preferred.

Technical/Process/Functional Knowledge:
Expert in the areas of environmental monitoring, trending of environmental results, water sampling, gowning practices & current aseptic processing area sanitization practices.

Organization/Planning:
Strong organizational skills & ability to create & maintain cycle plans for four shifts of personnel.

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

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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: 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.

Basic Qualifications
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