Senior Quality Control Technical Analyst

Novo Nordisk•Boulder, CO

4d•Onsite

About The Position

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 Technical Analyst to support both the successful start-up and ongoing operation of the Quality Control laboratory supporting early phase manufacturing. The Senior Quality Control Technical Analyst will: Own all activities related to the establishment & operation of Novo Nordisk’s Global LIMS platform for support all aspects of the QC Chemistry laboratory implementation of instruments, reagents, methods, workflows supporting analysis of raw materials, in-process, final product samples, as well as routine stability samples. In addition, this position is responsible for the oversight and SME for iStability representing the system to Boulder as well as other Novo sites throughout the world. This position is for a hands-on analyst familiar with Novo systems (iStability and Global LIMS) and processes as they relate to GMP Quality Control.

Requirements

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
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, Global LIMS, iStability and Microsoft Project)
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
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) required

Nice To Haves

Experience with computerized laboratory systems (iStability, Global LIMS, etc.) preferred
Demonstrated knowledge of adult learning methodologies & is able to use multiple methods to train & coach others within the department & organization preferred
Demonstrates understanding of project management and NN gate process flow preferred

Responsibilities

Serve as QC Global LIMS Site SuperUser and Site Builder responsible for training and building QC methods
Serve as the Global lead for iStability, responsible for training other Novo sites
Serve as the Boulder QC lead for iStability responsible for managing the system, generation of reports and data as requested by internal groups
Write/revise SOPs, technical protocols, change control and other quality related reports
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
Understand the processes of data evaluation and trending, to include reporting findings to leadership
Represent Boulder QC on global and site level as needed for collaboration with other NN sites
Interact professionally with external vendors to solicit new technology
Interact closely with all areas to improve the flow of information & products
Follow all safety & environmental requirements in the performance of duties
Other accountabilities, as required