This position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Will assist in the internal audit program and be a QA presence on the manufacturing floor.
Reports to: Supervisor, Quality Assurance.
Main Job Tasks:
* Performs walk-through audits of NNUSBPI Manufacturing facilities.
* Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance.
* Review and assess Corrective and Preventive Actions.
* Reviews and approves validations and technical reports.
* Reviews and assesses deviations; includes tracking, follow-up and reporting/trending.
* Reviews manufacturing and support records to certify compliance with specifications and procedures.
* Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and deviation issues.
* Assists in performing and reporting internal and vendor audits as scheduled.
* Participate in Regulatory Inspections.
* 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 and 10 Essentials in all activities and interactions with others.
* Other duties as assigned.
* Travel: 5-10%.
Knowledge, Skills and Experience:
* Bachelor’s Degree (or equivalent) required, a scientific discipline preferred
* A minimum of three (3) years of GMP-related experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience.
* Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors. KEY
* Excellent written and verbal communication and negotiating skills are required.
* Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken.
* Normally receives little to no instructions for routine work, and general instructions for new assignments.
* Strong planning and organization skills, with flexibility for changes in work priorities.
This position has the ability to be releveled based on candidate experience.
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...cont.