The PositionProvides support to Quality Control (QC) by driving continuous improvement, optimization and innovation as well as leading systematic problem solving and change requests. Works with members of the departmental leadership team to share best practices with NN departments/sites & external vendors. Based on assigned area of responsibility, may work with LIMS and/or QC initiatives.
RelationshipsReports to Manager, QC Support.
Essential Functions- Serve as QC Global LIMS Site SuperUser and QC Static Builder responsible for training and building of QC methods
- Responsible for driving continuous improvement, innovation and optimization projects
- Responsible for driving change requests and assisting with large scale investigations (QMT)
- Lead & coach peer analysts and leaders in problem solving for small-scale process & quality issues
- Understand the processes of data evaluation and trending, to include reporting findings to leadership
- Represent QC on global level and interact/collaborate with other NN sites
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned
Physical RequirementsMoves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.
Qualifications- Bachelor's degree in science or technical field from an accredited university required or equivalent combination of education and experience required
- May consider an Associate Degree in science or technical field from an accredited university required with a minimum of seven (7) years QC experience
- Minimum of five (5) years of QC experience in a pharmaceutical or related (regulated) environment required
- Leadership/Supervisory experience preferred
- Demonstrated foundational understanding of processes, procedures & products associated with assigned areas required
- Perform detailed analysis of events & processes, develop appropriate responses to situational needs & convey information/results to various organizational levels as appropriate required
- Demonstrated knowledge of adult learning methodologies & can use multiple methods to train & coach others within the department & organization preferred
- Knowledge & understanding regarding departmental processes & their high-level inter-relationships required (i.e. how they work together to establish a system)
- Excellent verbal & written communication skills, investigative writing skills & computer skills (MS Word, Outlook, Excel, PowerPoint & LIMS) required
- Demonstrates ability to manage multiple tasks/deadlines & prioritize properly based on process needs & events required
