Associate, Quality Control

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

The Associate Quality Control performs day-to-day quality control activities while ensuring accuracy timeliness and compliance with applicable regulatory requirements and company procedures. Responsibilities may include sample collection and preparation laboratory testing data review and analysis documentation and support of laboratory operations. This role contributes to the successful start-up operation and continuous improvement of quality control activities in support of manufacturing and development operations. Entry and analysis procuring and maintaining lab supplies.

Relationships

Reports to Senior Manager Quality Control.

Essential Functions

• Perform routine and non-routine GMP and non-GMP sampling and testing
• Execute sample receipt preparation testing data collection and documentation activities
• Utilize laboratory systems and software to enter review and maintain Quality Control data and records
• Analyze compile and report laboratory results in support of Quality Control activities
• Support investigations deviations corrective and preventive actions (CAPAs) and change controls as assigned
• Draft revise review and maintain laboratory documentation including standard operating procedures forms training materials and other controlled documents
• Ensure department documents are current standardized and uploaded appropriately within the Novo Nordisk Quality Management System (QMS)
• Support laboratory readiness activities including equipment materials inventory and general laboratory operations
• Collaborate with internal stakeholders external suppliers and service providers as needed to support Quality Control operations
• Support training and onboarding activities as appropriate
• Contribute to continuous improvement initiatives and operational excellence activities
• Support evolving business and laboratory needs in a start-up environment including additional quality control-related responsibilities within the scope of the role
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with applicable healthcare laws regulations and industry codes
• Follow all safety and environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

0-10% overnight travel required. Able to Aseptically gown and enter clean room. Able to lift 25 lbs. Able to work flexible hours as required by the process.

Qualifications

• Bachelors degree from an accredited university and 0 years of experience required. Degree within Microbiology/Biology/Chemistry/Life Sciences or related field preferred.
• Preferred experience within the Pharmaceutical/Biotech industry
• Experience with the application of cGMPs USP/NF EuPH. FDA guidelines and ICH guidelines with the pharmaceutical industry required
• Experience writing standard operating procedures and other cGMP documentation required
• Experience writing deviation and/ or change control preferred
• Experience working in a GMP Quality Control laboratory environment preferred
• Experience with laboratory instrumentation and computerized laboratory systems preferred
• Experience with electronic quality and laboratory systems (e.g. LIMS CDS QMS) preferred
• Excellent organizational and multi-tasking skills attention to detail and the ability to adapt to changing priorities
• Ability to handle conflicts
• Solutions oriented and good at making decisions under time pressure
• Excellent organizational and communication skills required

The base compensation range for this position is $70400 to $96800. 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 positions 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 July 27 2026. The Company may however extend this time-period in which case the posting will remain available on our careers website at -us/.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve 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 whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.