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Associate, Quality Control

Company: Kal--o
Location: Richmond
Posted on: May 16, 2022

Job Description:

Job DescriptionThis position is located in Richmond, Virginia. Remote candidates will NOT be considered.Kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions. We were founded by patients, and patients remain our central focus and common passion.The Quality Control Associate is responsible for the review, trending, and retention of analytical data as it relates to commercial release, stability, and product development. This person will work directly with various testing suppliers on a daily basis ensuring timely execution of protocols, data integrity, and support internal/external investigations as needed. Additionally, this person will compile and/or review reports for submission to regulatory agencies.The Quality Control Associate will work as part of a highly motivated Quality Assurance team where the patient is our focus and quality and compliance are #1. This is an opportunity to join a team of talented professionals, work with a life-saving product, and gain career-defining experience through exposure to many areas of the pharmaceutical industry. As a Quality Control Associate you will:

  • Provide supplier oversight for commercial, stability, and product development testing; including site visits, where applicable
  • Identify and escalate trends in analytical data (e.g., Out-of-Trend (OOT))
  • Initiate, coordinate, and/or support both internal and external investigations (e.g., Out-of-Specification (OOS))
  • Develop, review, and approve analytical testing protocols (drug and device)
  • Review analytical testing data reports (drug and device)
  • Maintain data collection tools used for Key Performance Indicator (KPI) tracking
  • Participate in KPI Meetings
  • Prepare Statements of Work (SOW) and Purchase Orders (PO) with suppliers as necessary
  • Prepare stability sections of Annual Product Quality Reviews (APQRs), FDA Annual Reports (ARs), and as required for various regulatory submissions
  • Review and approve supplier invoices
  • Participate as an Subject Matter Expert (SME) during internal and supplier audits, when applicable
  • Develop, review, and approve departmental Standard Operating Procedures (SOPs)
  • Management of Change Requests, Issues, Deviations and Corrective Action/Preventative Actions (CAPAs) within the Quality Management System, when applicable
  • Actively participate in QA/QC related initiatives
  • Actively contribute as a member of the Quality Assurance/Quality Control teamA successful Quality Control Associate will have:
    • Must have the ability to manage multiple priorities/projects, resolve issues, and work in a fast-paced and flexible environment
    • Must possess confidence and be able to communicate with all levels of personnel
    • Must be able to work with external laboratory and manufacturing partners
    • Strong understanding of data analysis tools and root cause analysis
    • Strong oral and written communication skills with the ability to articulate technical information in a clear and concise way
    • Commitment to fostering an inclusive environment across the organizationTo be considered for the position, you must have:
      • Bachelor's degree in Life Sciences
      • 1+ years' experience working in a GMP laboratory and/or stability program management
      • Understanding of Current Good Manufacturing Practices (CGMPs), United States Food & Drug Administration (FDA) and International Council for Harmonisation (ICH) guidance documents related to Stability and data integrityAdditional preferred qualifications:
        • Experience with electronic quality systems for documentation and processes (e.g., MasterControl) preferred
        • Bachelor's degree in Chemistry is preferred

Keywords: Kal--o, Richmond , Associate, Quality Control, Other , Richmond, Virginia

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