Senior Quality Control Equipment Analyst
Boulder, CO, US
About the Department
The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference.
The Position
Novo Nordisk, CMC Boulder, is building a Phase 1 and 2 API Pilot facility for oligonucleotide manufacturing in Boulder Colorado. As such, the Quality Control team is seeking a Senior Quality Control Equipment Analyst to support both the successful start-up and ongoing operation of the Quality Control laboratory supporting early phase manufacturing.
The Senior Quality Control Equipment Analyst will: Own all activities related to the establishment & operation of the Quality Control Chemistry laboratory as it relates to equipment qualification and subsequent PM’s and annual qualification. The position will also act as a back-up Global LIMS SME for the facility. This position is highly visible to Sr Management and is intended for a self-starter. This position is for a hands-on analyst familiar with Novo systems (TIMS, Global LIMS) and processes as they relate to GMP Quality Control.
Relationships
Reports to Senior Manager, Quality Control.
Essential Functions
- Serve as QC lead (Equipment Responsible) for analytical equipment qualification to support the Boulder CMC API facility
- Perform analytical equipment qualification and preventive maintenance, including hands-on execution and/or coordination with equipment vendors when activities are outsourced
- Responsible for documenting the qualification and maintenance of analytical instrumentation, using Quality generated protocols and reports from the TIMS system when possible
- Coordinate with internal subject‑matter experts and equipment vendors to troubleshoot and resolve equipment issues
- Serve as the QC lead for the TIMS system a back-up for Global LIMS QC Super User
- Assist with material qualification as needed
- Develop processes, procedures and or protocols for QC lab equipment such as, but not limited to: HPLC, UHPLC, GC, Karl Fisher, UV, pH, Conductivity, TOC, endotoxin, ICP-MS and FTIR
- Write/revise SOPs, technical protocols, change control and other quality related documentation
- Lead & coach team members, other specialists, providing leadership in problem solving for process & quality issues
- Evaluate and support corporate initiatives for new technology and process improvements
- Represent Boulder QC on global and site level as needed for collaboration with other NN sites
- Interact closely with QC analysts, analytical development, facilities, engineering, and quality assurance to ensure alignment with relevant stakeholders
- 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
- High School Diploma or GED and 8+ years of experience, or Associate's degree with 6+ years of experience, or Bachelor's degree from an accredited university and 4+ years of experience, or Master's degree and 2+ years of experience is required
- QC experience in a pharmaceutical or related (regulated) environment required
- Experience with computerized laboratory systems (TIMS, Global LIMS, etc.) 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
- Excellent verbal & written communication skills, investigative writing skills, & computer skills required (MS Word, Outlook, Excel, PowerPoint, TIMS, and Global LIMS)
- 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)
The base compensation range for this position is $99,600 to 184,200. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
The job posting is anticipated to close on April 7th, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.