Senior Quality Control Specialist

BioSpace; Boulder (CO); On-site; USD 128,000 - 155,000; Full time

Benefits offered by this job

Bonus eligibility

Job summary

Novo Nordisk's Boulder site seeks a Senior QC Specialist to assist with management and oversight of QC testing and reporting performed at Contracted Manufacturing and Testing Organizations. This role covers testing and ongoing stability of unique API starting materials, Drug Substance and Drug Product, providing QC support to Development, CMC, Operations, QA/QC and Regulatory Affairs.

The ideal candidate will bring 4+ years of QC experience in biotech/pharma GMP environments, strong analytical

Qualifications

• BS/BA in science related field or equivalent experience with 4+ years of related Quality Control experience in biotech or pharmaceutical position, particularly in a GMP environment.
• Ability to perform analytical methods, interpret and trend stability data including, but not limited to: Chromatography (IP-RP-UPLC/ SAX-HPLC/ GC) Mass Spec, FTIR, metals testing, residual solvents, vapor pressure and freezing point osmolality, UV, pH, endotoxin, sterility and bioburden
• Knowledge of FDA cGMP regulations, ICH and FDA Guidances for Industry, Compendial requirements, other-country regulations and standards
• Expertise in data analysis including reviewing, reporting and trending data.
• Strong problem solving/analytical skills
• The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism
• Excellent written and verbal communication skills, strong negotiation and decision-making skills and attention to detail are equally important
• Strong organizational skills, with the ability to handle multiple tasks in a fast-paced environment

Responsibilities

• Demonstrate technical proficiency in analytical methodology and ensure quality control activities are carried out according to and with adherence to regulatory and internal requirements, cGMP and ICH compliance
• Create, revise, review and approve protocols, supporting analytical data and reports associated with method validation, testing and release of GMP starting materials, intermediates, Drug Substances and Drug Products
• Serve as QC lead on analytical project teams and product operational teams
• Conduct or support investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results
• Write/revise SOPs, technical protocols, change control and other quality related reports
• Work with the Quality management team to continuously improve the quality, compliance and efficiency of QC operations
• Effectively communicate internal issues related to performance, processes and procedures
• Be a self-starting problem solver who drives results through high compliance and a positive work style

Skills

Analytical methods proficiency

Data analysis

FDA cGMP knowledge

Chromatography

Mass Spectrometry

FTIR

Problem solving

Communication

Organizational skills

Education

BS/BA in science related field

Job description

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.

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 Senior QC Specialist will assist with management and oversight of QC testing and reporting performed at Contracted Manufacturing and Testing Organizations. This includes testing and ongoing stability of unique API starting materials, Drug Substance and Drug Product. Assist in all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides QC support to the Development, CMC, Operations, QA/QC and Regulatory Affairs departments.

Relationships

Reports to Quality Control Manager.

Essential Functions

• Demonstrate technical proficiency in analytical methodology and ensure quality control activities are carried out according to and with adherence to regulatory and internal requirements, cGMP and ICH compliance
• Create, revise, review and approve protocols, supporting analytical data and reports associated with method validation, testing and release of GMP starting materials, intermediates, Drug Substances and Drug Products
• Serve as QC lead on analytical project teams and product operational teams
• Conduct or support investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results
• Write/revise SOPs, technical protocols, change control and other quality related reports
• Work with the Quality management team to continuously improve the quality, compliance and efficiency of QC operations
• Effectively communicate internal issues related to performance, processes and procedures
• Be a self-starting problem solver who drives results through high compliance and a positive work style

Qualifications

• BS/BA in science related field or equivalent experience with 4+ years of related Quality Control experience in biotech or pharmaceutical position, particularly in a GMP environment
• Ability to perform analytical methods, interpret and trend stability data including, but not limited to: Chromatography (IP-RP-UPLC/ SAX-HPLC/ GC) Mass Spec, FTIR, metals testing, residual solvents, vapor pressure and freezing point osmolality, UV, pH, endotoxin, sterility and bioburden
• Knowledge of FDA cGMP regulations, ICH and FDA Guidances for Industry, Compendial requirements, other-country regulations and standards
• Expertise in data analysis including reviewing, reporting and trending data.
• Strong problem solving/analytical skills
• The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism
• Excellent written and verbal communication skills, strong negotiation and decision-making skills and attention to detail are equally important
• Strong organizational skills, with the ability to handle multiple tasks in a fast-paced environment

Compensation

The base compensation range for this position is $127,500 to $155,400. 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.

Benefits

• 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.

Application Closing

The job posting is anticipated to close on August 6, 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.

Equal Opportunity

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.

Equal Opportunity Employer

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.

Accommodation

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.