Lead Technician, Quality Assurance - Parenteral (Night Shift)

Eli Lilly and Company; Pleasant Prairie (WI); On-site; Full time

Job summary

An established industry player is seeking a Lead Technician in Quality Assurance to enhance its manufacturing operations. This role involves providing oversight for GMP processes, ensuring compliance with regulations, and collaborating with cross-functional teams to resolve issues. Candidates should possess extensive experience in the pharmaceutical sector and demonstrate strong communication and technical writing skills. Join a dynamic team dedicated to improving lives through innovative healthcare solutions while enjoying a comprehensive benefits package and opportunities for professional growth.

Benefits

401(k) plan

Pension plan

Medical benefits

Dental benefits

Vision benefits

Vacation benefits

Employee assistance program

Fitness benefits

Company bonus

Qualifications

• 5+ years in the pharmaceutical industry with QA oversight experience.
• Understanding of cGMP regulations and experience in GMP environments.

Responsibilities

• Provide QA oversight to GMP operations on the night shift.
• Review and approve GMP documentation and support SOP creation.
• Troubleshoot equipment alarms and maintain quality systems.

Skills

Quality Assurance

cGMP regulations

Technical Writing

Root cause analysis

Communication Skills

Interpersonal Skills

Attention to detail

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (here) for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $28.12 - $46.88.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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