Senior Quality Control Process Technical Analyst

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 12 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

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 / Companywide across 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 interact/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

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.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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.