Requisition ID 43730BR<br/>Title QC Environmental Monitoring Associate<br/>Job Category Quality<br/>Job Description<br/>NNUSBPI is growing! We have an exciting new opportunity in our Quality Control Department. This position has primary responsibility to support operations for the QC Department. This position will be the site lead for the environmental monitoring program residing within QC. It has primary responsibility to plan, coordinate, author and report issuance for the Environmental Monitoring (EM) program.<br/><br/>Relationships:<br/><br/>Reports to: Head of Quality Control<br/><br/>Main Job Tasks:<br/><br/>* Author’s protocol and reports to support EM program qualification activities.<br/>* Function as the project manager of the EM program.<br/>* Schedules and coordinates with external EM program resources.<br/>* Liaison between internal Manufacturing and QC Microbiology for scheduling and coordination of activities as needed.<br/>* Coordinates data flow for both routine and study activities.<br/>* Leads multi-disciplined projects, with minimal supervision.<br/>* Complete understanding/application of quality systems with the ability to manage Change Controls.<br/>* Supports data review and trending and issuing of monthly trend reports.<br/>* Leads EM procedure revision and creation.<br/>* Issues and tracks EM deviations and able to assist in root cause analysis.<br/><br/>* Supports CAPAs with assisting in corrective action implementation.<br/>* Supports Health Authority inspections.<br/>* Provide training on Environmental Monitoring to QC Micro team and Manufacturing as needed.<br/>* Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes. Incorporates the Novo Nordisk Code of Conduct values in all activities and interactions with others.<br/><br/>Knowledge, Skills and Experience:<br/>* Bachelor’s degree or equivalent in microbiology, biological sciences or related field with eight or more years of experience.<br/>* Complete knowledge of regulatory requirements for environmental monitoring of cleanroom areas.<br/>* Requires full understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines.<br/>* 1 to 3 years project management experience. Ability to manage/lead projects and coordinate activities between both internal and external groups.<br/><br/>* Has ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniques.<br/>* Excellent organizational and communication skills.<br/><br/>Department NNUSBPI - QUALITY CONTROL<br/>Position Location US - Lebanon, NH<br/>City West Lebanon<br/>State/Provinces US - NH
<br/><br/>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
<br/><br/>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!
<br/><br/><p class="eeo_desc">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.<br/><br/>
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.<br/><br/>
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