Quality Control Analyst II - SDF

Novo Nordisk•Durham, NC

1d•Onsite

About The Position

The Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of innovative oral treatments for patients with type 2 diabetes. This facility maintains a curious and pioneering spirit, harmonious with its growing pipeline of new products and emerging technologies. The Quality Control Analyst II will perform and review analysis of in-process, release, and stability samples in accordance with cGMP, site, and corporate procedures and policies. This role also involves the transfer of technology and processes in accordance with relevant project plans and timelines.

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.
Must demonstrate attention to detail required.

Nice To Haves

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.
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.

Responsibilities

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.
Maintain testing proficiency for methods.
Ensure timeliness of lab results & investigations.
Analysis of Samples.
Author Deviations.
Coaching other analysts.
Data Trending & Tracking.
Ensure departmental documents are current & standardized.
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.