Quality Control Analyst I (Microbiology)

Novo Nordisk • Clayton, NC

7d

About The Position

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy 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 & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Perform & review analysis of in-process, release & stability samples of API &/or filled product in accordance with cGMP, site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines. Relationships Reports to Manager. Essential Functions 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 Physical Requirements Moves 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 color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

Requirements

• Associate’s degree in science or a relevant field of study from an accredited university required
• One (1) year of work experience in a clinical or industrial/pharmaceutical laboratory preferred
• Demonstrate attention to detail required
• Strong communication skills (verbal & written) preferred

Nice To Haves

• Bachelor’s Degree in science or a relevant field of study from an accredited university preferred
• Ability to author scientific & technical reports is a plus
• Able to perform routine testing per SOP & GMP standards preferred
• Basic level of troubleshooting for laboratory equipment is a plus
• Knowledgeable in GMP & laboratory techniques is a plus
• 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) is a plus

Responsibilities

• Perform & review analysis of in-process, release & stability samples of API &/or filled product in accordance with cGMP, site & corporate procedures & policies.
• Transfer of technology & processes in accordance with relevant project plans & timelines.
• 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

Benefits

• Leading pay and annual performance bonus for all positions
• All employees enjoy 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 & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees