Quality Control Analyst I - IV Micro

About the position

This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This position requires strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing and may support sampling, investigations, validations, projects and other related support activities for the manufacturing facility and process. This individual works with supervision on routine tasks and detailed instruction on new tasks.

Responsibilities

• Independently performs low complexity testing (e.g. Bioburden, Spectroscopy, Environmental Monitoring)
• Executes moderate complexity testing with minimal support (e.g. Microbial Identification, HPLC, SDS-PAGE)
• Performs high complexity testing with support (e.g. Bacterial Endotoxin, ELISA, UPLC)
• Completes routine equipment maintenance/calibration
• Supports equipment qualifications or method verification/validation activities
• Participates in deviations and laboratory investigations
• Update standard operating procedures with help
• Delivers training on low complexity tasks
• Performs troubleshooting with support
• Contributes to cLEAN activities (e.g. PDCA, SPS, VSM)
• Lead or support projects with limited scope
• Documents and archives work in accordance with Good Documentation Practice
• Identifies continuous improvement opportunities
• Present standard requests during audit/inspections
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Other duties as assigned

Requirements

• Associate's degree in a scientific discipline required
• Bachelor's degree in scientific discipline preferred
• Associate's degree with three (3) years of relevant experience required
• Bachelor's degree with one (1) year of relevant experience preferred
• Pharmaceutical, Biotechnology or other regulated industry experience preferred
• Knowledge of laboratory practices required (such as aseptic technique, use of pipettes, pH etc.)
• The ability to understand and execute established written instructions is essential
• Good organization and documentation skills
• Strong Attention to detail
• Ability to prioritize tasks
• Ability to train others

Benefits

• Leading pay and annual performance bonus for all positions
• 36 Paid days off including vacation, sick days & company holidays
• Health Insurance, Dental Insurance, Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 14 weeks Paid Parental Leave
• Free access to Novo Nordisk-marketed pharmaceutical products