Lead Technician, Quality Assurance - Parenteral (Night Shift)

Eli Lilly and Company; Indiana (PA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Lead Technician in Quality Assurance to oversee GMP operations during night shifts. This role is crucial in ensuring compliance and safety in manufacturing processes, especially in parenteral filling and visual inspection. The ideal candidate will have a strong background in quality assurance within the pharmaceutical sector, demonstrating teamwork and communication skills to facilitate cross-functional collaboration. Join a forward-thinking company committed to improving lives through innovative healthcare solutions, and contribute to groundbreaking projects that make a real difference.

Qualifications

• 5+ years in pharmaceutical industry with quality assurance experience.
• Understanding of cGMP regulations and GMP production environments.

Responsibilities

• Provide QA oversight to GMP operations on the night shift.
• Review and approve GMP documentation and support SOP creation.
• Communicate compliance issues and support investigation.

Skills

Quality Assurance

cGMP regulations

Root cause analysis

Technical Writing

Communication Skills

Interpersonal Skills

Education

High school diploma or equivalent

Tools

Master Control

LabVantage

Veeva

Job description

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 Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Lead Technician, Quality Assurance – Parenteral is responsible for providing QA oversight to GMP operations occurring on the night shift. The role will demonstrate teamwork by collaborating cross functionally with various levels of the organization, supports issue resolution, and escalates issues from manufacturing to the site-based process teams for one of the following manufacturing areas:

• Formulation and Equipment Preparation Processes
• Parenteral Filling (Pre-Filled Syringes)
• Visual Inspection

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Supports on-the-floor manufacturing activities with routine presence in the assigned manufacturing area.
• Follows good documentation practices and compliance with site procedures.
• Reviews and approves GMP documentation such as electronic batch record annotations, logbook entries.
• Supports creation of Standard Operating Procedures and associated Forms, Tools and Training.
• Troubleshoots and provides support to resolve equipment alarms and other issues in quality systems such as Master Control or other Manufacturing Execution Systems.
• Maintains open communications between cross functional teams and area leadership.
• Supports the execution of inspection readiness activities including support of site self-inspections.
• Supports project initiatives as required for the site.
• Communicates any compliance issues as identified to Quality Management.
• Evaluates potential product quality impact for any GMP-related incident and supports the investigation.

Basic Requirements:

• High school diploma or equivalent.
• Minimum 5 years in the pharmaceutical industry with specific Quality Assurance production oversight experience (e.g., formulation, equipment preparation, isolator filling, visual inspection).
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Proficiency with applicable computer systems such as Master Control, LabVantage, Veeva.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Technical Writing and Communication Skills.

Additional Information:

• Primary location is Kenosha County, Wisconsin.
• Ability to work 12 hour shifts onsite on a rotating 2-2-3 or similar schedule on night shift (not eligible for remote work).
• Overtime and off-shift support may be required.
• May be required to respond to operational issues outside of core business hours and days.
• 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 employment positions on the B paths.