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QC Analyst, Critical Reagent/Reference Standard Inventory Management

San Rafael, CA 94901

Posted: 09/22/2023 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11422 Pay Rate: $30.00 - $34.00 Remote Friendly:

Job Description

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.


Position Overview:
  • This is a temporary QC 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 support an integrated inventory management database for reference standards and critical reagents.
  • The integrated inventory management will allow for the distribution of material to internal and external quality control laboratories.
  • The individual is expected to perform routine job functions independently with minimal supervision.
  • The QC Analyst is expected to build effective relationships/partnerships and communicate well within the Quality organization.

Responsibilities: 
  •  Assess the current reference standard and critical reagent inventory management for distribution to internal and external Quality Control Laboratories.
  • Prepare shipments for the distribution of reference standard and critical reagent to external Quality Control Laboratories.
  • Keep track of material requests and shipment progress.
  • Identify the minimal inventory level that triggers the process for obtaining and qualifying critical reagents and reference standards.
  • Perform preventive maintenance for freezers and/or storage units.
  • Creation of testing protocols in Laboratory Information Management System (LIMS).
  • 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.

Job Requirements

Core Competencies:
  • Ownership and Accountability - Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks what can I do to help?
  • Communication - Ability to communicate effectively up and down, at all levels of the organization, 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 statement clearly and accurately and apply 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, looks ahead to predict future customer needs. Manages expectations.

Required Skills:
  • Minimum 2 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.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!