Quality Control Analyst III

About This Role

This Quality Control Analyst role performs and reviews analyses of in-process, release, and stability samples of API and/or filled products, ensuring compliance with cGMP, site, and corporate policies. The position involves transferring technology and processes and providing leadership to other analysts in their daily tasks.

Responsibilities

• Perform and review analysis of in-process, release, and stability samples of API and/or filled product in accordance with cGMP, site, and corporate policies and procedures
• Transfer technology and processes in accordance with relevant project plans and timelines
• Provide leadership for other analysts as they execute their daily tasks
• Ensure accuracy and scientific soundness of lab data
• Ensure environmental compliance
• Support and ensure GMP Laboratory Compliance
• Maintain testing proficiency for methods
• Ensure timeliness of lab results and investigations
• Perform analysis of samples
• Author deviations
• Coach other analysts
• Perform data trending and tracking
• Develop process competence across IFP/API
• Drive process improvement for Site QC
• Ensure all Analyst testing of samples is complete, as needed
• Ensure departmental documents are current and standardized
• Perform Laboratory Equipment Validation and System support
• Provide Laboratory IT System support
• Leverage solutions to other NNPILP sites
• Perform deviation and change control activities
• Support other NNPILP sites when relevant
• Support deviations
• Participate in Systematic Problem Solving
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Requirements

• Bachelor ’s Degree from an accredited university required
• May consider an Associate ’s Degree from an accredited university with seven (7) years of relevant experience in a clinical or industrial/pharmaceutical laboratory required
• Five (5) years of experience in a clinical or industrial/pharmaceutical laboratory required
• Ability to author scientific and technical reports required
• Able to perform routine testing per SOP and GMP standards required
• Advanced level knowledge in GMP and laboratory techniques required
• Demonstrate attention to detail required
• Serve as a subject matter expert on QC processes required
• Strong communication skills (verbal and written) required
• 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) required

Nice to have:

• Advanced level of troubleshooting for laboratory equipment preferred
• Validation and technical transfer experience preferred
• Project Management experience is a plus
• Change control, deviation, trending preferred

Benefits

• Annual performance bonus for all positions
• Generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental and 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life and Disability Insurance
• Employee Referral Awards
• Opportunities, resources, and mentorship to help grow and build your career

Important Details

• Reports to: Manager

Physical Requirements

• Move equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Ability to do close precision work with 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

About the Company

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes and obesity. In NC, the company operates three pharmaceutical manufacturing facilities, including the Emerging Technologies - Solid Dosage Forms US facility in Durham, NC, a 194,000 square foot tableting and packaging facility that supports the production of innovative oral treatments for patients with type 2 diabetes. Novo Nordisk is driven by a single purpose to defeat serious chronic diseases and help millions of people live healthier lives, creating lasting change for long-term health.