Printed Packaging Materials Lead Technician

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.

Position Title:

PPM Lead Technician - QA

Position Type:

Full-Time

Job Level:

B4

Location:

Indianapolis, LTC-S

Job Function:

Quality Assurance

Position Posted:

Supervisor:

Sr. Manager or Assoc Director - Quality

Internal Posting Dates:

Position Brand Description:

The Printed Packaging Material - Quality Assurance Lead Technician will work in the Indianapolis Device Assembly & Packaging site where products for domestic and international markets are assembled and packaged. The primary purpose of the position is to provide daily support and technical oversight for the safety and inspection of high-quality printed packaging materials utilizing Lilly standards by following good manufacturing practices.  The Lead Technician works as a team member with a focus on leading the inspection of these materials and abiding by the Lilly culture of integrity, excellence, and respect for people.

Key Objectives / Deliverables:

• Responsible for training and the completion of all requirements for the qualification of new Printed Packaging Material Inspection team members
• Serve as coach / mentor to QA Technician team to ensure continuous learning on quality processes and systems
• Support process improvements to help improve productivity within the local process team or quality organization
• Assist the QA Team Leader with additional requests as needed
• Review and analyze Lilly printed packaging materials at incoming inspection according to standard operational procedures (SOPs).
• Utilize calibrated text verification system, databased computer systems, and measurement tools to perform inspection.
• Review production data for PPM batch release
• Provide support for the production area, as applicable, for issues arising around printed packaging materials
• Organize, critically review, and present information in accordance with written procedures
• Ensure compliance with applicable procedures, cGMP's policies, and regulations
• Communicate effectively with customers and quality representatives to evaluate and reinforce requirements
• Apply experience and knowledge of cGMP requirements
• Work independently on inspections ensuring that printed material inspections meet customer due dates and quality needs
• Work within QA Technician team to ensure all team members receive QA support needed to maintain daily operations

Management of Controlled Substances, if applicable:

• Comply with all established requirements to receive and maintain authorization to handle controlled substances.

• Successfully complete the background check process.
• Complete the training assigned to your learning plan within the established due dates.
• Report drug diversion.
  • Any employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer, as established in the Code of Federal Regulations
    CFR 1301.91.

• Report illicit activities by employees:
  • You are responsible under state, federal and local law, and Lilly policy to report to your supervision and Global Security any irregular or unauthorized employee activities involving controlled substances / drugs (e.g., unauthorized or illicit possession, manufacture, use, distribution, theft, diversion, or destructions), as established in the Code of Federal Regulations 21 CFR 1301.92.

Minimum Requirements:

• IDAP PPMQA inspection experience
• At least two years of pharmaceutical manufacturing experience
• Must be able to pass vision screening
• Proficiency with applicable computer systems
• Strong oral and written communication and interpersonal skills
• Strong attention to detail
• Ability to work with constant changes, time pressure, interruptions, and distractions

Additional Preferences:

• Experience with cGMP’s
• Proven ability to take initiative, work independently or as part of a team to resolve an issue

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