Device & Packaging Quality Flow Mentor

BioSpace; Indianapolis (IN); On-site; USD 63,000 - 163,000; Full time

Job summary

A leading global healthcare company seeks a Device & Packaging Quality Flow Mentor in Indianapolis. The ideal candidate will provide technical leadership, coaching QA representatives, and supporting process optimization in a dynamic environment. This role requires extensive knowledge in quality systems and a Bachelor’s degree in a relevant field.

Benefits

Comprehensive benefit program

Company-sponsored 401(k) and pension

Flexible benefits including healthcare spending accounts

Qualifications

• Bachelor’s degree or higher is required.
• Minimum of three years' experience in cGMP operations.
• Experience in device assembly and packaging processes is preferred.

Responsibilities

• Coach and mentor QA floor reps in onboarding and qualification.
• Lead investigations for quality function.
• Analyze process team metrics for identification of improvement opportunities.

Skills

Oral and written communication

Problem-solving

Attention to detail

Decision making

Education

Bachelor’s degree in sciences, engineering, or related field

Tools

Quality Systems knowledge

Manufacturing process knowledge

Job description

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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 35,000 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

The Indianapolis Device Assembly & Packaging (IDAP) quality assurance flow mentor provides technical leadership and expertise for quality production support in the following areas: coaching and mentoring QA floor reps, developing and sustaining process knowledge, process and equipment support, process optimization and continuous improvement, sustaining quality management systems, and adherence to business processes. The flow mentor participates in regulatory inspections, collaborates in the site inspection readiness program, supports the APR process, and advises lead investigators, functional leaders, and site quality leader on production issues.

Responsibilities

• Coach and mentor QA floor reps through onboarding and qualification.
• Coach and mentor QA floor reps in process understanding, problem solving, project management, and deviation resolution.
• Support and peer review root cause analysis around operational events.
• Promote and peer review documentation of learning points, gap assessments, and deviations.
• Provide technical support to non-routine investigations and lead investigations for the quality function.
• Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives.
• Provide process and equipment support through identification of systemic issues affecting production (deviations, cycle time delays, etc.)
• Lead or participate in root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations.
• Perform reviews of event documentation for technical accuracy and compliance.
• Provide back up and shutdown support for QA floor reps as needed.
• Identify and drive alignment of QA systems across IDAP.
• Support APR program.
• Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation.
• Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives.
• Collaborate with key support groups around the development of process knowledge and a common process improvement agenda.
• Provide independent peer input / review of technical activities.
• Provide support to the QA organization for deviation reduction and backlog prevention initiatives.
• Analyze process team metrics for awareness and identification of potential improvement opportunities.
  
  
  

Basic Requirements

• Bachelor’s degree or higher in the sciences, engineering, or related relevant field
• Minimum of three years' experience in cGMP operations
  
  
  

Additional Skills/Preferences

• Demonstrated strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
• Demonstrated attention to detail.
• Demonstrated ability to organize and prioritize multiple tasks.
• Experience in Quality, TS/MS, or engineering is preferred.
• Experience in device assembly and packaging processes.
• Good knowledge of cGMP, external regulations and Lilly quality systems and requirements.
• Experience leading root cause investigations.
• Excellent technical writing skills.
• Ability to function in a team environment as a leader and as a member of teams.
• Ability to partner / network outside the IDAP site and participate in inspection readiness / continuous improvement initiatives.
  
  
  

Additional Information

• The normal schedule for this position is Monday - Friday, 8 hours/day. However, back-up for floor QA reps and planned shutdown support may require support outside the normal schedule.
• 0-10 % Travel (domestic and international) may be required.
• Applicant may work in various areas within the IDAP plant. Some allergens are present in the IDAP plant.
  
  
  

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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

$63,000 - $162,800

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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