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Sr. Associate, Quality Operations

ICONMA, LLC
  • Princeton, NJ
  • $26.58–$29.58 Per Hour
  • Quick Apply
15 days ago

Job Description

Our client, a Pharmaceutical company, is looking for a Sr. Associate, Quality Operations for their Princeton, NJ/Hybrid location.
 
Responsibilities:
  • Responsible for assigned operational Quality Risk and Compliance (QRC) activities supporting Research and Development (R&D) quality efforts, including inspection readiness (IR), process improvement, training, and other assigned duties.
  • This role works closely with Quality Operations and internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs.
  • Receives assignments in the form of objectives.
  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Determines how to use resources to meet schedules and goals.
  • Works on issues of diverse scope which require evaluation of a variety of factors and an understanding of functional area objectives and trends.
  • Audit and Inspection Readiness (IR)
  • Support Quality operations activities to ensure continuous audit and inspection readiness.
  • Assist with inspection preparation activities, including tracking and closure of IR actions across multiple parallel workstreams, preparation of meeting minutes, scheduling of meetings, coordinating trainings, etc.
  • Coordinate cross-functional input as needed to support timely and effective resolution of mock inspection Corrective and Preventive Actions (CAPA) and commitments.
  • Support regulatory inspections by serving as a scribe and processing inspection requests as assigned.
  • Assist with post-inspection activities, including implementation of lessons learned and follow-up actions.
  • Support development of dashboards, metrics, and visualizations (e.g., Smartsheet, Power BI) to monitor functional performance against assigned Inspection Readiness (IR) activities.
  • Process Improvement/Project Management
  • Support coordination of and/or participate in process improvement initiatives.
  • Prepare and maintain meeting materials, project trackers, and metrics reports to support project execution, status reporting, and stakeholder communication.
  • Assist with process mapping and workflow documentation as needed.
  • Training
  • Support biennial R&D curriculum reviews to ensure training assignments and content remain relevant, and compliant with applicable regulatory and quality requirements.
  • Help organize and prepare for quality-related training workshops.
  • Support identification and/or development of quality eLearning and other training offerings.
  • Track new and revised controlled documents, including follow-up with curriculum owners on training changes and processing of Adobe Forms.
  • Other Quality Operations Support
  • Prepare materials and facilitate QRC department meetings as assigned.
  • Support the Quality Risk Management group in developing, tracking and maintaining study quality, compliance and training metrics, as needed.
  • Other duties as assigned/required
 
 
Requirements:
  • Detail-oriented with strong organizational, project management, and communication skills.
  • Ability to manage multiple projects, workstreams, and activities while adapting to changing priorities.
  • Strong interpersonal skills with ability to work effectively both independently and in cross-functional teams.
  • Demonstrated analytical skills with ability to organize, evaluate and interpret data, metrics, trends.
  • Working knowledge of clinical trials, GxP principles and Quality Management Systems.
  • Proficient computer skills, including Microsoft Word, PowerPoint, Excel and related business applications.
  • Experience with Veeva Systems, Power BI and Smartsheet software is preferred.
  • Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization
  • Bachelor’s degree in Science or a related field with a minimum of 2 years of relevant experience within the pharmaceutical or biotech industry, including experience in Quality, Clinical Operations, Project Management and/or other R&D function.
  • An equivalent combination of relevant education and experience may be considered.
 
Why Should You Apply?

Numbers & Facts

LocationPrinceton, NJ
Salary$26.58–$29.58 Per Hour

Skills

  • Adobe Product Familyunmatched
  • Analysis Skillsunmatched
  • Biometricsunmatched
  • Biotech and Pharmaceuticalunmatched
  • Business Solutionsunmatched
  • Calendar Managementunmatched
  • Clinical Practices/Protocolsunmatched
  • Clinical Trial Managementunmatched
  • Communication Skillsunmatched
  • Computer Skillsunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Detail Orientedunmatched
  • Document Managementunmatched
  • Documentationunmatched
  • Drug Developmentunmatched
  • GxPunmatched
  • Health Planunmatched
  • Healthcare Qualityunmatched
  • IR (Infrared)unmatched
  • Interpersonal Skillsunmatched
  • Medical Affairsunmatched
  • Meeting Minutesunmatched
  • Metricsunmatched
  • Microsoft Excelunmatched
  • Microsoft PowerPointunmatched
  • Microsoft Wordunmatched
  • Multitaskingunmatched
  • Operational Supportunmatched
  • Operations Managementunmatched
  • Operations Processesunmatched
  • Organizational Skillsunmatched
  • Performance Analysisunmatched
  • Pharmacovigilanceunmatched
  • Power BIunmatched
  • Problem Solving Skillsunmatched
  • Process Improvementunmatched
  • Project Executionunmatched
  • Project/Program Managementunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Reporting Dashboardsunmatched
  • Research & Development (R&D)unmatched
  • Riskunmatched
  • Risk Managementunmatched
  • Time Managementunmatched
  • Training/Teachingunmatched
  • Training/Teaching Curriculumunmatched
  • Translational Researchunmatched
  • eLearningunmatched

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