9185 QC Sr. Analyst, Critical Reagent and Reference Standard Inventory Management

Novato, CA

Duties: 

  • This is a temporary QC Sr. Analyst position in the Quality Control Analytical Technologies (QCAT) organization with a specific focus on the centralized program management of reference standards and critical reagents used in the testing of clinical and commercial products.  
  • The core function of this role is to establish an integrated inventory management database for reference standards and critical reagents.  
  • The integrated inventory management database will allow for the reporting of material inventory levels and determining material consumption rates to avoid stock-out situations.
  • The individual is expected to perform routine job functions independently with minimal supervision. 
  • The QC Sr. Analyst is expected to build effective relationships/partnerships and communicate well within the Quality organization.
  • Develop and establish an integrated inventory management database.
  • Assess the current reference standard and critical reagent inventory management in internal and external Quality Control Laboratories.
  • Assist with the establishment of lead times required for the resupply of qualified critical reagents and reference standards.
  • Identify the minimal inventory level that triggers the process for obtaining and qualifying critical reagents and reference standards.
  • Support the transformation of the established process to an electronic solution for efficient, sustainable, planned & predictable performance.
  • Proactively measure and improve process health.
  • Provide routine status reports on the inventory levels to Critical Reagent and Reference Standard Inventory Management.
  • Escalate if the inventory is at a critical level to Critical Reagent and Reference Standard Inventory Management.
  • Ensure all individual training and guidelines are kept current.
  • Manage and complete assigned projects, as needed.
  • Assist with regulatory and internal inspections, as needed.


Ownership and Accountability: 

  • Takes accountability for actions, drives results, and can learn from mistakes. 
  • Delivers on promises, goals, and expectations. 
  • Makes quality decisions and resolves problems with minimal delay as appropriate.
  • Asks what I can do to help.


Communication:

  • Ability to communicate effectively up and down, at all levels of the organization, and present complex and/or new ideas with clarity and simplicity.  
  • Ability to draft and deliver clear and concise procedures.


Planning: 

  • Excellent planning and prioritization skills with the ability to multitask and adapt.  
  • Able to synthesize large amounts of information.  
  • Able to deliver results despite shifting environment.


Analytical Problem Solving: 

  • Ability to identify problems, define problem statements clearly and accurately, and apply the structured and disciplined methodology to identify data-driven root causes.  
  • Innovative and effective in solution development, risk mitigation, and execution.


Customer focus:

  • Partners with customers and looks ahead to predict future customer needs. 
  • Manages expectations.

 

Skills: 

  • Minimum 4 years of experience in a Quality/Compliance/Regulatory setting.
  • Basic knowledge of cGMPs and equivalent industry regulations.
  • Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.


Education: 

  • BS in a technical science field.


PLEASE NOTE:

Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.