Quality Control Analyst I

Role Summary

Perform and review analysis of in-process, release and stability samples of API and/or filled product in accordance with cGMP, site and corporate procedures and policies. Transfer of technology and processes in accordance with relevant project plans and timelines. Based in Clayton, NC, this role supports quality control activities at Novo Nordisk's Product Supply Aseptic Manufacturing facility.

Responsibilities

• Ensure accuracy & scientific soundness of lab data
• Ensure environmental compliance
• Support & ensure GMP Laboratory Compliance
• Maintain testing proficiency for methods
• Ensure timeliness of lab results & investigations
• Perform analysis of samples
• Support deviations
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

• Required: Associate’s degree in science or a relevant field of study from an accredited university
• Preferred: Bachelor’s Degree in science or a relevant field of study from an accredited university
• Preferred: One (1) year of work experience in a clinical or industrial/pharmaceutical laboratory
• Preferred: Ability to author scientific & technical reports
• Preferred: Able to perform routine testing per SOP & GMP standards
• Preferred: Basic level of troubleshooting for laboratory equipment
• Preferred: Knowledgeable in GMP & laboratory techniques
• Required: Demonstrate attention to detail
• Preferred: Strong communication skills (verbal & written)
• Preferred: Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, pH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis)

Additional Requirements

• Moves equipment and/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 require corrected vision to 20/25 based on role
• May require color vision based on role
• Occasionally ascends/descends a ladder
• May be required to work at elevated heights
• Occasionally works around odorous and/or hazardous materials