Quality Assurance Process Team Device and Packaging - Associate

Eli Lilly-posted 7 months ago
$63,000 - $162,800/Yr
Full-time • Mid Level
Onsite • Concord, NH
Chemical Manufacturing
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring lifechanging medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

  • Demonstrate leadership, teamwork, and quality knowledge on a day to day basis.
  • Lead, mentor, and coach operations and support personnel on quality matters.
  • Provide support on deviations, change controls, procedure updates, commissioning, and qualification activities.
  • Maintain a regular presence in the operational areas to monitor and confirm execution according to quality standards.
  • Participate on the local process team for Device Assembly or Packaging.
  • Provide quality oversight for the verification and qualification of manufacturing equipment and buildings.
  • Review test cases, test execution, and resolve discrepancies.
  • Guide the leveling, resolving, reviewing, and approving deviations and change controls.
  • Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems, and operations.
  • Lead and establish annual quality floor time plan.
  • Support resolution of batch documentation such as alarm response and exceptions.
  • Support asset qualification monitoring reviews and reports.
  • Respond to operational issues outside of core business hours/days as required.
  • Attend and provide updates on quality at daily process team meetings.
  • Support the site organization in building technical capability in Quality and mentoring new Quality staff.
  • Resolve or escalate compliance issues to Quality Management.
  • Identify and implement continuous improvements.
  • Measure, maintain, and achieve quality metrics.
  • Serve as positive role models for their Process Team peers and for the organization.
  • Bachelors or equivalent degree in a scientific field.
  • 4+ years' experience in Quality pharmaceutical manufacturing required.
  • Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
  • Use process knowledge and control strategy to make quality decisions.
  • Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing.
  • Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
  • Ability to work independently as a Quality SME with minimal supervision.
  • Proficiency with computer systems including SAP, Trackwise, MES etc.
  • Responsible for maintaining a safe work environment.
  • Ability to work 8 hour shifts onsite (not eligible for remote work).
  • Ability to work overtime as required.
  • ASQ Certified.
  • CSQA experience.
  • Previous experience with device assembly or packaging.
  • Previous experience with Manufacturing Execution Systems.
  • Previous use of KNEAT or other electronic validation software.
  • Previous technical writing experience.
  • Eligibility to participate in a company-sponsored 401(k).
  • Pension benefits.
  • Vacation benefits.
  • Eligibility for medical, dental, vision and prescription drug benefits.
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
  • Life insurance and death benefits.
  • Certain time off and leave of absence benefits.
  • Wellbeing benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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