- 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, and 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.
- Manages expectations.
- 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.
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.