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Quality Assurance Lead

Company: Elanco
Location: Winslow
Posted on: February 25, 2021

Job Description:

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below. Position Description: As a member of a team dedicated to ensuring regulatory compliance for a network of vaccine manufacturing sites, the role will:

  • Partner with external consultants to compare existing practices (Outlines of Production, Batch records, work-instructions, control strategies, etc.) to current compliance requirements (9 CFR)
  • Develop a strategy (priority, timeline, owners, etc.) for improvements
  • Actively execute the strategy
  • Periodically present progress to Executive Leadership Though developing a strategy is a necessary component of this role, the focus is on the execution of the strategy-completing the improvements identified in the plan. This role will report to the manufacturing Site Head but will have significant exposure to executive leadership throughout the entire process. Functions, Duties, Tasks:
    • Partner with functional leaders, Site Head, external consultants, subject matter experts, and executive leadership to develop a compliance roadmap for the vaccine manufacturing site(s)
    • Responsible for the execution and delivery of improvements through individual assignments and leading project teams
    • Create, present, and lead training on improvements to processes or procedures
    • Use technical skills to lead or perform in-depth investigations, which may include participating in or leading change controls and deviations
    • Communicate progress to off-site steering team
    • Replicate process for other vaccine manufacturing sites in the network Minimum Qualification (education, experience and/or training, required certifications):
      • Bachelor of Science degree in Biology, Microbiology, Biochemistry, Engineering or other related scientific field.
      • Experience with 9 CFR and USDA
      • Strong interpersonal communication skills
      • Demonstrated ability to execute complex projects
      • Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable. Additional Preferences:
        • MS or PhD preferred
        • Experience providing technical support and/or regulatory support in a manufacturing environment
        • Experience in Lean, Six-Sigma or Operational Excellence
        • Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office Other Information:
          • Travel may be required
          • PPE required in some working areas
          • Relocation assistance may be provided
          • Employee may be based at any of our US Elanco locations Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Posted 5 Days Ago Full time R0004957 About Us Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose--- CSR framework - all to advance the health of animals, people and the planet. Learn more at www.elanco.com .

Keywords: Elanco, Evansville , Quality Assurance Lead, Other , Winslow, Indiana

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