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Stability Coordinator

Company: Kelly Services
Location: Framingham
Posted on: April 10, 2021

Job Description:

Stability Coordinator, Lexington, Massachusetts, 2421 (Supporting local in Lexington and Boston plus global. Position will start remote but eventually will be onsite)--Kelly Services is seeking a Stability Coordinator, will help manage data, compiling information, consolidation. GMP data stability, understanding quality systems in the GMP background. PHARMA experience is important. Team structure- global team supporting multiple projects. Day to Day- stability data consolidating into global databases and reporting it out to staff. Reports/ presentations/ working closely with senior members to consolidate effort. Technologies: MS applications, experience in Minitab JMP or Discoverant is needed for one of our top clients in Lexington, MA.--Length: 02/22/2021 to 12/31/2021 (Contract W2)- (Possibility to extend or convert)Pay Rate: $40.00/hr. (W2)--Description:

  • Support Specialists in the Project Management of Stability Studies for Drug Products, Drug Substances and Intermediates as well as associated Data Evaluations and Documentation
  • Support data analysis activities, including trending of stability data for multiple products
  • Authoring of technical documents
  • Supporting ongoing activities in EQMS systems including (LIMS, Discoverant, and others)
    • Support ongoing stability programs and objectives
    • Support compilation and analysis of stability data for compliance to end of shelf life expectations
    • Support operational activities related to stability quality systems, including Discoverant, LIMS, and other software applications
    • Support the analysis of and detection of stability alerts (OOTs)
    • Support the development and training initiatives of statistical applications for stability management
    • Experienced in GMP regulations and compliance requirements
    • Knowledge and understanding of ICH and other regulatory requirements.
    • Experience with various quality systems (e.g. LIMS)
    • Fluent in English (written and oral)
    • Technical writing skills.
    • Conducts work in compliance with cGMPs, safety and regulatory requirements
    • Relevant experience with pharmaceutical pipeline products and CMC aspects of regulatory filings.
    • Experience in Discoverant or other statistical software (e.g. JMP, Minitab) a plus
    • Scientific knowledge in protein / plasma / antibody chemistry / small molecule products
    • Good analytical and problem solving abilities
    • Experienced in working with global teams--Leadership:
      • Be Positive
      • Be Accountable
      • Be Results Oriented
      • Be An Excellent Manager of Self and Others
      • Team Player
      • Good Communication Skills
      • Seeks and considers feedback
      • Global Cultural Awareness
      • Ability to prioritize work and multitask.--Education:
        • Typically requires Bachelor in Science or Engineering or several years of experience in pharmaceutical Industry Science related degree is preferred.--Apply Today! Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Framingham , Stability Coordinator, Other , Framingham, Massachusetts

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