Eli Lilly

Principal/Senior Principal/Advisor - QA Flow Mentor IAPI

Eli Lilly • $65K — $169K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Yesterday
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in scientific or engineering discipline required.
  • 5+ years of experience in a technical support area (e.g., Engineering or Technical Services).
  • 2+ years of experience in Quality Assurance (QA).
  • Technical knowledge of chemical processing and process equipment.
  • Strong computer skills in software packages such as Visio, Trackwise, Veeva, and MS Project.

Responsibilities

  • Coach and mentor front-line QA representatives in key QA support functions.
  • Lead qualification efforts for new frontline QA team members.
  • Identify systemic production issues and drive corrective actions.
  • Collaborate with cross-functional teams to implement QA objectives.
  • Review and approve documentation to ensure compliance with quality standards.
  • Support large-scale initiatives aimed at productivity and compliance improvements.

Benefits

  • Comprehensive benefits package including medical, dental, and vision insurance.
  • 401(k) and pension eligibility along with company bonuses.
  • Generous vacation and leave of absence benefits.
  • Access to employee well-being programs, including fitness benefits and club activities.
  • Support for professional development through training and knowledge sharing opportunities.
Full Job Description
Position Brand Description:

The QA Flow Mentor provides technical leadership and expertise for production operations in the areas of: Coaching and Mentoring Front Line Process QA Reps, Developing and Sustaining Process Knowledge, Process & Equipment Support, Process Optimization & Continuous Improvement, Developing and Sustaining Quality Systems, and Adherence to Business Systems.

Key Objectives/Deliverables:

Coach and Mentor Front-Line QA Reps
  • Lead Qualification efforts for new frontline QA reps.
  • Coach and mentor front-line process QA reps in aspects of fundamental QA support including process understanding (both theoretical and practical), problem solving, project management, and deviation resolution.
  • Related experiences with troubleshooting bio-purification and traditional unit operations such as chromatography, tangential flow filtration, fermentation, homogenization, evaporation, mixing, and distillation.
  • Champion the application of statistical thinking and use of data to monitor process performance and make risk-based QA decisions.
  • Support and peer review root cause analysis around operational events.
  • Promote and peer review documentation of learning points, Gap assessments, and event investigations.
  • Provide technical support to non-routine (e.g., deviation) investigations.
  • Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives.


Provide Process & Equipment Support
  • Identify 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 front-line QA reps
  • Act as the liaison between central services groups (e.g., Q Engineering) and the process teams and participate/lead implementation of central services initiatives (as needed/appropriate).
  • Participate in the APR process

Process Optimization & Continuous Improvement
  • Review, identify and drive alignment of QA systems across IAPI.
  • 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 quality oversight/approval of Periodic Reviews for Direct Impact systems to ensure constant state of qualification.
  • Provide quality oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure that equipment/systems are appropriate for the intended purpose and comply with applicable Global Quality Standards/Engineering Standards.
  • Provide independent peer input/review of technical activities.


Adherence to QA/Business Systems
  • Provide support to the QA organization for deviation reduction and backlog prevention initiatives.
  • Chair the Deviation Review Board / Change Review Board
  • Analyze process/unit team metrics for awareness and identification of potential improvement opportunities:
    • Deviation Cycle Time
    • Event Root Causes
    • Overdue CAPA items


Basic Requirements:
  • Bachelor's required in scientific/engineering discipline
  • 5+ years of work experience in a technical support area (e.g., Engineering, TS/MS).
  • 2+ years of work experience in Quality Assurance.
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.


Additional Preferences:
  • Technical knowledge of chemical processing and process equipment.
  • Ability to function in a team environment as a leader and as a member of teams.
  • Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
  • Knowledge of protein chemistry & process/cleaning validation.
  • Ability to partner/network outside the IAPI site and demonstrated participation in inspection readiness/continuous improvement initiatives.
  • Statistical thinking
  • Technical knowledge of chemical processing and process equipment.
  • Ability to function in a team environment as a leader and as a member of teams.
  • Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
  • Knowledge of protein chemistry & process/cleaning validation.
  • Ability to partner/network outside the IAPI site and demonstrated participation in inspection readiness/continuous improvement initiatives.
  • Advocate for training and knowledge sharing
  • Communication skills
  • Develop and implement innovative approaches to problems
  • Successful application of root cause analysis and systematic problem solving
  • Strong computer skills in a variety of software packages (Visio, Trackwise, Veeva, MS Project)


Other Information:
  • The normal schedule for this position is Monday-Friday, 8 hours/day. However, emergency situations may require additional support beyond this normal schedule.
  • Little to no travel is required with this position.
  • Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.


This role is located in Indianapolis, IN and requires the individual to be onsite.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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