Standard Operating Procedure Designer - Lincoln, Nebraska

AI overview

Define, develop, implement, and maintain standard procedures ensuring compliance with regulatory requirements and governance as part of global project groups.
Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is currently seeking a full-time Standard Operating Procedure Designer for our Lincoln, Nebraska location. After 6-8 weeks of on-site training, you will have the ability to work primarily from home, if desired. You will work with your team in person and on-site every other week. This role also offers the ability to be fully office-based as well. In this position, you will define, develop, implement and maintain Celerion standard processes that adhere to company governance and global regulatory requirements. Responsibilities:
  • Lead global project groups to obtain information needed to create global process documents.
  • Plan for and manage reviews of new and existing processes and standards to ensure completeness, consistency, quality and compliance with established requirements.
  • Manage document control and maintenance process for all Celerion processes and standards.
  • Ensure processes and standards are compliant with regulatory requirements, corporate governances and the Quality Management System.
  • Develop, coordinate and facilitate training programs for appropriate processes and standards.
  • Requirements:
  • Bachelor's degree in Life Sciences or related degree preferred
  • Excellent oral and written communication skills
  • High proficiency in MS Office applications and Adobe Acrobat
  • Excellent organization skills
  • Strong facilitation, presentation and training skills
  • Self-motivated and able to perform with minimal supervision
  • Celerion Values:       Integrity   Trust   Teamwork   Respect

    Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
    Salary
    $22 – $23 per hour
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