QC Environmental Monitoring Supervisor- (Off Shift)

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 life-changing 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.

Company Overview:

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 39,000 employees around the world work to discover and bring life-changing 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.

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.  The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

What You'll Be Doing:

The QC Environmental Monitoring Supervisor will provide oversight and supervision of the QC Environmental Monitoring Technicians. The QC Environmental Monitoring Supervisor will coordinate environmental monitoring activities to be performed in support of Parenteral Operations and routine facility monitoring requirements. Additionally, the QC Environmental Monitoring Supervisor will assist in training QC Environmental Monitoring Technicians and will provide alternate support in performing environmental monitoring activities as required.

Key Objectives/Deliverables:

• Ensure and enforce compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
• Provide supervision and oversight of the QC Environmental Monitoring Technicians during the day-to-day activities, including any non-routine day-to-day activities (i.e., Media Fills, EM PQs) that may arise based on production needs.
• Coordinate environmental monitoring activities and assign job responsibilities to QC Environmental Monitoring Technician(s).
• Perform technical training and mentor QC Environmental Monitoring Technicians through formal process/program.
• Provide alternate support in assisting with routine or non-routine environmental monitoring activities as required.
• Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.
• Author and review Standard Operating Procedures, Work Instructions/Tools, and assist with development of the QC Environmental Monitoring Technician’s Learning and Development (Training) Plans.
• Facilitate development for all direct reports, including but is not limited to coaching/mentoring of QC Environmental Monitoring Technicians, establishing goals, and providing performance improvement and performance recognition feedback.
• Comply with and assist in implementing safety standards.
• Support internal and external audits when necessary.
• Support EM investigations (excursions, nonconformance) as needed.  

Minimum Requirements:

• Associate degree or equivalent, Bachelor’s (4-year) degree in a science related field is preferred.
• 4+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
  • 1-2 plus years supervisory experience preferred.
• Experience in environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis.
• Experience with Laboratory IT systems such as LIMs, LES, and MODA.

Additional Preferences:

• High level of experience with cGMP requirements, compliance, and regulatory guidance associated with a cGMP Pharmaceutical Manufacturing facility.
• Ability to focus on continuous improvement.
• Ability to work in a lab environment including wearing appropriate PP