QC Supervisor

Company Overview
Nanosphere, Inc. (NASDAQ: NSPH) is a nanotechnology-based molecular diagnostics company, offering proprietary breakthrough technologies that provide a unique and powerful solution to greatly simplify molecular diagnostic testing.

Based in Northbrook, IL, Nanosphere employs approximately 110 people. Nanosphere's diagnostic platform has several FDA cleared tests and the company continues with its ambitious growth plans of rapidly bringing new tests and device platforms with enhanced capabilities to the marketplace.

Position Overview
Nanosphere is committed to recruiting an outstanding Quality Control Supervisor during a critical period of the Company's growth and evolution.  The QC Supervisor will report to the Company's Director of Analytical Chemistry, and will serve as a key member of the Quality Control team.

A key success factor for this position is the ability to work in a fast paced, cross functional group environment, with a willingness to be hands-on across a wide area of responsibilities.

This ideal candidate is someone with diverse experience and great capacity and desire for taking on new responsibilities and challenges as the company grows.
 

Key Responsibilities:

  • Supervises QC staff in the testing of environmental samples, raw materials, reagents, intermediates, and final product
  • Ability to conduct and complete laboratory and OOS investigations
  • Ensures that generated data is applicable for use in product submissions to the FDA
  • Assists R&D groups with design requirements and specifications, as needed
  • Drafts/revises/reviews/approves quality control test methods, SOP protocols, and reports
  • Liaises with quality assurance, manufacturing, product development, and R&D groups to meet all company requirements
  • Assists with the design execution of experiments to improve quality of final product and provides insights into possible causes and corrective actions
  • Provides support for analytical test method and process validation activities
  • Provides expertise with QC documentation requirements in compliance with CFR Part 820
  • Conducts interviews as needed for review/selection of staff

Experience and Requirements:

  • Bachelor's degree in Chemistry/Biochemistry
  • 7+ years experience in Quality Control, preferably in a FDA regulated environment
  • Good working knowledge of statistics
  • Background/experience with stability program requirements
  • Knowledgeable with current Quality Systems Regulations
  • Must have good knowledge and understanding of current analytical techniques
  • Must have excellent flexibility with time management
  • Must be adaptable with frequently changing priorities
  • Must have excellent interpersonal and communication skills
  • Must have demonstrated leadership capabilities