The PositionThe 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.
RelationshipsReports 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
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.
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 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.
