Quality Control Analyst III - Microbiology

Novo Nordisk-posted 10 months ago
Clayton, NC
5,001-10,000 employees
Ambulatory Health Care Services
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

Perform & review analysis of in-process, release & stability samples of API and/or filled product in accordance with cGMP, site & corporate policies & procedures. Transfer of technology & processes in accordance with relevant project plans & timelines. Provide leadership for other analysts as they execute their daily tasks.

  • Ensure accuracy & scientific soundness of lab data
  • Endure environmental compliance
  • Support & ensure GMP Laboratory Compliance
  • Maintain testing proficiency for methods
  • Ensure timeliness of lab results & investigations
  • Perform analysis of samples
  • Author deviations
  • Coach other analysts
  • Perform data trending & 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 & standardized
  • Perform Laboratory Equipment Validation & System support
  • Provide Laboratory IT System support
  • Leverage solutions to other NNPILP sites
  • Perform deviation & change control activities
  • Support other NNPILP sites when relevant
  • Support deviations
  • Participate in Systematic Problem Solving
  • Follow all safety & environmental requirements in the performance of duties
  • Other accountabilities, as assigned
  • 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 & technical reports required
  • Able to perform routine testing per SOP & GMP standards required
  • Advance level knowledge in GMP & laboratory techniques required
  • Demonstrate attention to detail required
  • Strong communication skills (verbal & 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
  • Change control, deviation, trending preferred
  • Project Management experience is a plus
  • Advanced level of troubleshooting for laboratory equipment preferred
  • Validation & technical transfer experience preferred
  • Leading pay and 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 & 6 weeks paid family medical leave
  • Free access to Novo Nordisk-marketed pharmaceutical products
  • Tuition Assistance
  • Life & Disability Insurance
  • Employee Referral Awards
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Quality Control Analyst Resume Examples
•
Quality Control Analyst Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service