Analyst, Quality Control - Raw Materials

NovartisDurham, CA
1dOnsite

About The Position

The Analyst, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring conformance to established quality processes and standards for manufacturing and production. Location: This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Requirements

  • Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field.
  • Learns to use professional concepts.
  • Applies company policies and procedures to resolve routine issues.
  • Ability to communicate and work in a team environment.
  • Normally receives detailed instructions on all work.

Responsibilities

  • Execute routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to chromatography (HPLC, UPLC), AUC, SEC, compendial assays (pH, Conductivity, Osmolality), electrophoresis (CE, Western Blot) and assist with data review.
  • Execute method verifications/transfers as required for various projects.
  • Assist with enrollment of vendors, ordering reagents and consumables for new assays.
  • Perform sampling of incoming materials as required for use in manufacturing and production.
  • Initiate all paperwork (LIMS, SOPs, assay forms) for testing and transfers of methods for projects.
  • Responsible for limited range of laboratory support functions and procedures as assigned, developing capability in basic technical skills, disciplines, and procedures within assigned discipline area(s).
  • May be assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook/equipment use and maintenance, and updates to existing operating procedures.
  • Capable of delivering to assigned work schedule with attention to detail and accuracy.
  • Notifies management and initiates events (such as Laboratory Investigations) in the quality systems, with guidance from senior analysts or management.
  • Assist in special projects on analytical and instrument problem solving by execution of assay.
  • Gain familiarity with basic process improvement methodologies, learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment.
  • Other related job duties as assigned.

Benefits

  • Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
  • US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
  • In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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