Job Description
Critical Reagent and Reference Standard Inventory Management\u00A0Senior Associate\u00A0\u00A0The Critical Reagent and Reference Standard Inventory Management\u00A0Senior Associate\u00A0reports to the Associate Manager in Quality Control Analytical Technology.\u00A0\u00A0The\u00A0core function\u00A0of this\u00A0role\u00A0is\u00A0to\u00A0support and maintain\u00A0the\u00A0centralized program management\u00A0of reference standards and critical reagents used in the testing\u00A0and release\u00A0of clinical and commercial products.\u00A0The\u00A0role is responsible for\u00A0all\u00A0activities related to\u00A0monitoring\u00A0material\u00A0consumption rates,\u00A0material\u00A0inventory levels\u00A0and\u00A0all\u00A0qualification/requalification\u00A0tasks required to support reference standards and critical reagents supply.RESPONSIBILITIESDetailed responsibilities include but are not limited to the following:Monitors and supports the\u00A0integrated\u00A0inventory management process.Act as a technical resource for reference standards and critical reagents\u00A0for\u00A0internal and external\u00A0Quality\u00A0Control Laboratories\u00A0and\u00A0other\u00A0departments, as needed.Participate in the reference standard qualification document lifecycle\u00A0\u2013 authoring, review, approval, etc.Responsible for\u00A0critical reagent and reference standard\u00A0preparation,\u00A0qualification\u00A0testing coordination\u00A0and release for use.Prioritize projects to meet timelines to ensure on-time delivery of results and establish priorities for\u00A0final\u00A0reports.Review of\u00A0stability trend graphs for reference materials and drug substance / drug product stability studies\u00A0to be used in reference requalification reports, and Product Quality Team updates.Supports/reviews\u00A0graphic trend analysis for annual reports, regulatory submissions (APR, YBPR, BLA, IND), and response letters for commercial/clinical products.Initiate\u00A0and assist with\u00A0quality\u00A0investigations, incident reports and\u00A0the\u00A0implementation of Corrective Actions and Preventative Actions.Provide support to the department leadership with the implementation of new systems and continuous improvement efforts.Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements.Maintain product quality by establishing and applying quality standards.Assist with regulatory and internal inspections, as needed.Core Competencies:Collaborative Leadership\u00A0- Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.\u00A0\u00A0High tolerance for ambiguity and able to create order from chaos.\u00A0\u00A0Builds credibility through solid relationships and solid track record of results.Ownership and Accountability\u00A0\u2013 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 \u201Cwhat can I do to help?\u201DCommunication\u00A0- Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.\u00A0\u00A0Ability to draft and deliver clear and concise procedures or business process documents.Planning - Excellent planning and prioritization skills with the ability to multitask and adapt.\u00A0\u00A0Able to synthesize large amounts of information.\u00A0\u00A0Able to deliver results despite shifting environment.Analytical Problem Solving\u00A0\u2013 Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.\u00A0\u00A0Innovative and effective in solution development, risk mitigation, and execution.Customer focus - Partners with customers, looks ahead to predict future customer needs. Manages expectations.EXPERIENCERequired Skills:Minimum\u00A04\u00A0years of experience in a Quality/Compliance/Regulatory settingSound knowledge of cGMPs and equivalent industry regulationsPrior experience with technical oversight of Deviations and CAPAsProficiency with computer systems \u2013 Microsoft Office SuiteProficiency with TrackWise or QMS, LIMS, Oracle, EDMS, and Office365 preferredEDUCATIONBS 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.\u00A0
