Principal/Senior Principal/Advisor - QA Flow Mentor IAPI

About the role

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.

Responsibilities

• 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.
• 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.
• Identify systemic issues affecting production (deviations, cycle time delays, etc.) and 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.
• 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.
• 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.
• 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.

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.

Qualifications

• Authorized to work in the United States on a full-time basis.

Skills

• 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.
• Successful application of root cause analysis and systematic problem solving.
• Strong computer skills in a variety of software packages (Visio, Trackwise, Veeva, MS Project).

Benefits

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.

Pay

Limited to $169,400

Schedule

The normal schedule for this position is Monday-Friday, 8 hours/day. However, emergency situations may require additional support beyond this normal schedule.

Other Information

• 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.
• Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
• 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).