Senior Quality Control Process Technical Analyst - Stability
Novo Nordisk USA
About the Department
You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.
FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
What we offer you:
• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Departmental Subject Matter Expert (SME) for technical analysis, process improvements & quality topics, to include driving continuous improvement, optimization, and innovation as well as leading systematic problem solving & change requests. Works with other members of the QC team to ensure systems are in place to drive process quality & area improvements, complete Quality Systems responses, ensure audit readiness & share ideas/solutions with NN departments/sites & external vendors. Based on assigned area of responsibility, may work with LIMS and/or QC initiatives.
Relationships
Reports to Manager, Quality Control Support.
Essential Functions
- Serve as QC Global LIMS Site SuperUser and QC Static Builder responsible for training and building QC methods
- Evaluate and support corporate initiatives for new technology and process improvements
- Responsible for driving change requests and leading large-scale investigations (QMT)
- Lead & coach junior team members, other specialists, leaders in problem solving for process & quality issues
- Gather data and perform analysis to support leadership in developing systems to improve processes & prevent recurrence of problems. Evaluate the results of process confirmations of standards for opportunities to leverage & share ideas for improvements Site / division / Company wideacross NNPILP. Track & assess effectiveness of corrective / preventative actions from audits/inspections/investigations
- Understand the processes of data evaluation and trending, to include reporting findings to leadership
- Represent QC on global level and intertact/collaborate with other NN sites
- Interact professionally with external vendors to solicit new technology
- Interact closely with all areas to improve the flow of information & products
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as required
Physical Requirements
Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time.
Qualifications
- Bachelor’s degree in science or technical field from an accredited university required or equivalent combination of education and experience required
- May consider an Associate’s Degree in science or technical field from an accredited university required with a minimum of nine (9) years QC experience
- Minimum seven (7) years of QC experience in a pharmaceutical or related (regulated) environment required
- Leadership/Supervisory/Project Management experience preferred
- Stability and/or sample management preferred
- Demonstrated expert understanding of processes, procedures & products associated with assigned areas required. Able to perform detailed analysis of events & processes, develop appropriate responses to situational needs, & convey information/results to various organizational levels as appropriate required
- Demonstrated knowledge of adult learning methodologies & is able to use multiple methods to train & coach others within the department & organization preferred
- Excellent verbal & written communication skills, investigative writing skills, & computer skills required (MS Word, Outlook, Excel, PowerPoint, LIMS and Microsoft Project)
- Demonstrated experience in practical problem solving & process improvement methods required
- Demonstrated ability to manage multiple tasks/deadlines & prioritize properly based on process needs & events. Demonstrated effectiveness in systematic follow-up required
- Understand the processes and products at an advanced level required
- Demonstrates understanding of project management and NN gate process flow preferred
- Expert level of knowledge & understanding regarding departmental SOP’s & their high-level inter-relationships required (i.e. how they work together to establish a system)
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
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.