Critical Reagent and Reference Standard Inventory Management Senior Associate
The Critical Reagent and Reference Standard Inventory Management Senior Associate reports to the Associate Manager in Quality Control Analytical Technology. The core function of this role is to support and maintain the centralized program management of reference standards and critical reagents used in the testing and release of clinical and commercial products.
The role is responsible for all activities related to monitoring material consumption rates, material inventory levels and all qualification/requalification tasks required to support reference standards and critical reagents supply.
Detailed responsibilities include but are not limited to the following:
- Monitors and supports the integrated inventory management process.
- Act as a technical resource for reference standards and critical reagents for internal and external Quality Control Laboratories and other departments, as needed.
- Participate in the reference standard qualification document lifecycle – authoring, review, approval, etc.
- Responsible for critical reagent and reference standard preparation, qualification testing coordination and release for use.
- Prioritize projects to meet timelines to ensure on-time delivery of results and establish priorities for final reports.
- Review of stability trend graphs for reference materials and drug substance / drug product stability studies to be used in reference requalification reports, and Product Quality Team updates.
- Supports/reviews graphic trend analysis for annual reports, regulatory submissions (APR, YBPR, BLA, IND), and response letters for commercial/clinical products.
- Initiate and assist with quality investigations, incident reports and the implementation 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 - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity and able to create order from chaos. Builds credibility through solid relationships and solid track record of results.
- 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 or business process documents.
- 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.
- Minimum 4 years of experience in a Quality/Compliance/Regulatory setting
- Sound knowledge of cGMPs and equivalent industry regulations
- Prior experience with technical oversight of Deviations and CAPAs
- Proficiency with computer systems – Microsoft Office Suite
- Proficiency with TrackWise or QMS, LIMS, Oracle, EDMS, and Office365 preferred
BS in a technical science field
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.