Supervisor - Quality Assurance Job
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POST DATE 8/20/2016
END DATE 11/12/2016
West Lebanon, NH
JOB DESCRIPTIONRequisition ID 42195BR
Title Supervisor Quality Assurance
Job Category Quality
Novo Nordisk US Bio Production Inc. is growing! We have a fantastic new opportunity for a Quality Assurance Supervisor to join our team. This position is responsible for the review of Manufacturing and Quality Control/Assurance records and support documentation to certify compliance with in-house specification / standards and GMP for all Novo Nordisk US Bio Production Inc. products. Responsible for the review of technical reports, validations, change control, nonconforming product reports, CAPA, equipment records, and final product release. As a supervisor, this position will also hire, train, develop, coordinate work and project assignments, support, and supervisor a team of QA Area Specialists. In the absence of the Sr. Manager, Quality Assurance, this position will be designated deputy with some signature authority.
Essential Duties and Responsibilities
* Oversees a staff of five plus (5+) individuals.
* Reviews manufacturing and support records to certify compliance with specification and procedures.
* Makes recommendation towards the release of product / process intermediates based on QA record review.
* Performing internal audits and vendor audits as scheduled.
* Assists in Deviations and Change Control, Corrective and Preventative Action tracking, follow-up, and reporting.
* Reviews validation protocols and summary reports as needed.
* Reviews Technical reports as needed.
* Assists in planning for, and active participation in, all Health Authority and other external audits.
* Other duties as assigned.
* 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 Way an Essentials in all activities and interactions with others.
* Travel: 0 10%
* Must be able to sit and/or stand for extended periods of time
Development of People:
* Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
* Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
* Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Knowledge, Skills and Experience:
* Four (4) year degree in a scientific discipline and three (3) to five (5) years of QC/QA experience in a pharmaceutical or biotechnology company and one (1) to three (3) years of supervisory experience preferred. A minimum of seven (7) years experience in a Quality role within the industry can be a substitute for a degree.
* Excellent communication skills and the proven ability to integrate into a team and manage complex projects.
* Strong planning and organizational skills, and flexibility to change work priorities as necessary.
* A minimum of five (5) years experience in a licensed drug, device, or biologic facility regulated by FDA, EMEA or a leading international agency in a quality role.
* Must have practical experience in working with the U.S. and international requirements for biologicals and/or biologically based medical devices.
Department NNUSBPI - QUALITY ASSURANCE
Position Location US - Lebanon, NH
City West Lebanon
State/Provinces US - NH
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.