QC Analyst, Critical Reagent and Reference Standard Inventory Management

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

THIS ROLE IS ONSITE ONLY 

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

Detailed responsibilities include but are not limited to the following:

• 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 externalQuality 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.

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.

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

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.