US-NC, QA Area Specialist - QC Job 396412600A1-MZ
|Requisition ID 45777BR|
Title QA Area Specialist - QC
Job Category Quality
Job Description Your Groundbreaking Journey
At Novo Nordisk, we want to make a difference. For more than 90 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.
To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.
Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.
Additional Information Position Purpose: Review/approval of NCs, approval of change requests/SOPs, review/approval of training material, approval of laboratory investigations (FP- IQC), approval of trend reports, supplier program management, performance of self audits (in conjunction with Line of Business), QA presence & process confirmation on shop floor, improvement to Quality processes.
* Ensure site compliance with regulations, ISO standards, & corporate/local SOPs.
* Review & approve change control requests.
* Review & approve user & system requirements.
* Participate in project teams as the compliance resource.
* Provide guidance to departments regarding quality-related activities
* Support root-cause analysis & review/approve cross-functional investigations.
* Participate in process confirmations & Go Look Sees.
* Participate in knowledge & experience sharing with other QA personnel to assure compliance with company procedures, policies & objectives.
* Evaluate trend & report data for QMRs & APR reports.
* Perform other duties as assigned.
BA/BS degree in Life Sciences, Engineering, or related field.
* 4 years of QA &/or quality related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
* Demonstrated expertise in regulations & quality management systems (examples: QC Methods & Operations, NC/CAPA, Change Control, Audits, product disposition)
* Familiarity with local processes & quality management systems.
* Demonstrated knowledge of critical controls & input/output requirements for API processes.
* Knowledge of Quality, Production, Business Support, QC, O&P &/or API Production processes.
* Knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in aseptic manufacturing.
* Excellent written & verbal communication skills.
* Basic computer skills in MS Office, Project, PowerPoint, Excel, etc.
* Internal Auditing experience with certification preferred.
* Experience in the use of Six Sigma & LEAN tools.
* Personal Time Management: Sets goals & prioritizes tasks for own work on short-term basis, meets deadlines & makes regular progress reports on performance.
* Keeps track of & informs management of fluctuation in workload.
* Performs well with multi-tasking.
* Adjusts priorities in accordance with changing circumstances.
* Keeps all relevant people informed of current & future plans.
Physical & Other Requirements:
* Ability to work in & around an active construction site.
* Ability to move throughout the facility in the performance of duties in proximity of process equipment & areas.
* Ability to work hours necessary & according to process needs.
* Must be able to travel internationally.
Department DAPI US - QA Validation
Position Location US - Clayton, NC
State/Provinces US - NC
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.
Please visit our website at www.novonordisk.com