9185 QC Sr. Analyst, Critical Reagent and Reference Standard Inventory Management
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.
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.
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.
Partners with customers and looks ahead to predict future customer needs.
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.
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.