Process Technician - QA Visual Inspection

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly RTP is a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. 
 

Responsibilities:

The Quality Assurance Visual Inspection Technician works as a member of the Statistical Sorting team and reports to the Sr. Manager- QA Visual Inspection. Responsibilities include performing AQL inspections, final classification of defects, sample management as well as providing QA oversight to GMP operations in the Parenteral visual inspection areas which includes automated visual inspection, semi- automated inspection, and manual inspection.  The QA Visual Inspection Technician oversees visual inspection production functions to achieve patient safety and site goals through effective quality oversight.

• Ensures regular presence in assigned parenteral areas to perform AQL inspections, manage sample collection/deliver to laboratories. 
• Responsible for adhering to safety rules and maintaining a safe work environment for yourself and others by supporting HSE corporate and site goals.
• Responsible for ensuring training is completed and remains in compliance.
• Communicates with QA Representative and Sr. Manager- QA Visual Inspection on quality and operational issues.
• Ensures adherence and understanding of good documentation practices and compliance with applicable procedures.
• Advise Visual Inspection Operations and support personnel on quality matters, while driving the site Quality culture.
• Execution of activities in electronic batch record (PMX), laboratory LIMS system (Darwin), and other systems as required (SAP, TrackWise).
• Participate in self-led inspections and provide support during internal / external regulatory inspections.

Basic Requirements:

• High School Diploma or equivalent
• Demonstrated experience in GMP facility
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
• Must pass a vision exam and be free of color blindness
• Must be equivalent to 20/20 correctable close vision acuity

Additional Skills/Preferences:

• Parenteral Inspection experience (automated, semi-automated and manual).
• Associate degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Strong understanding of quality systems in the inspection environment.
• Demonstrated strong oral and written communication and interpersonal skills to communicate to operators and management.
• Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
• Strong attention to detail and demonstrated organizational skills.
• Basic computer skills including Microsoft Office products, (Excel, Word, PowerPoint, Outlook), inventory control (SAP), and electronic batch records (PMX)
• Ability to work cross functionally and work collaboratively with all levels of the organization.
• Proven ability to work independently or as part of a team to resolve issues.

Additional Information:

• Ability to work 12-hour shifts on days (2-2-3 schedule).
• Ability to work overtime, as requested.
• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves, etc.) and follow site gowning requirements.
• Physical Demands: Light work that requires physical effort. Requires good communication skills, eye-hand coordination and manual skills. Occasionally requires force to raise, to load, and to push objects. Occasionally requires movements of the body like to incline, to climb, to kneel