Quality Control Analyst II
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Durham • North Carolina • United States
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About the role
- Perform & review analysis of in-process, release & stability samples in accordance with cGMP, site & corporate procedures & policies
- Transfer of technology & processes in accordance with relevant project plans & timelines
- Ensure departmental documents are current & standardized
- Maintain testing proficiency for methods
- Timeliness of Lab Results & Investigations
- Analysis of Samples
- Author Deviations
- Coaching other analysts
- Data Trending & Tracking
- Laboratory Equipment Validation & System support
- Laboratory IT System support
- Perform deviation & change control activities
- Supports Deviations
- Systematic Problem Solving
- Follow all safety and environmental requirements in the performance of duties
- Other accountabilities, as assigned
Requirements
- Minimum of a Bachelor’s degree in Chemistry or relevant field of study from an accredited university required or an equivalent combination of education and experience
- May consider an Associate’s degree in chemistry or relevant field of study from an accredited university with a minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory
- May consider a High School Diploma or GED with a minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratory
- Minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory required
- Ability to author scientific & technical reports preferred
- Able to perform routine testing per SOP & GMP standards preferred
- Change control, deviation, trending a plus
- Knowledgeable in GMP & laboratory techniques preferred
- Must demonstrate attention to detail required
- Serve as a subject matter expert on QC processes a plus
- Strong communication skills (verbal & written) preferred
- Troubleshooting for laboratory equipment a plus
- Validation & technical transfer experience a plus
- Skills or knowledge in the following discipline: Chemistry
- Analysis of tablets including UPLC and Dissolution preferred
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analysis of sampleslaboratory equipment validationdata trendingchange controldeviation authoringUPLCdissolution testingroutine testingGMP standardslaboratory techniques
Soft Skills
attention to detailstrong communication skillscoachingsystematic problem solving
Certifications
Bachelor’s degree in ChemistryAssociate’s degree in ChemistryHigh School Diploma or GED