QC Regulatory & Stability Area Specialist

Novo Nordisk•Durham, NC

22h•Onsite

About The Position

Responsible for supporting the stability & retain programs for Quality Control site. Support process & drive improvement activities based on process performance, event response & process confirmation. Ensures audit readiness & shares ideas & solutions with other departments & sites.

Requirements

Bachelor's Degree in Chemistry or related scientific field preferred or equivalent education & experience required
Minimum of two (2) years of experience with stability programs &/or regulatory relevant experience preferred
Strong communication skills (verbal & written) & the ability to author scientific & technical reports preferred
Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications preferred
Ability to control all aspects of the stability & retain programs a plus

Responsibilities

Responsible for preparing & updating stability protocols & reports
Trend stability data & initiate trend investigations
Responsible for providing stability & retain reports to corporate for annual product reviews
Track & ensure stability testing is completed on time
Write stability documents to support regulatory submission for new products
Write stability documents for all other regulatory requests
Support LIMS builds & training
Maintain stability & reference sample inventory (storage & discard of samples)
Stability representative during audits/inspections
Project team member for new product transfers
Other duties as assigned