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 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.

Reports to Senior Manager, Quality Control.

• 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

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.

• Bachelor's 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 $70,400 to $96,800. 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…