Quality Assurance Complaints Representative

BioSpace; Indianapolis (IN); On-site; USD 65,250 - 169,400; Full time

Benefits offered by this job

Comprehensive benefit program

401(k) participation

Pension benefits

Vacation benefits

Medical and dental insurance

Well-being benefits

Job summary

A global healthcare leader in Indianapolis seeks a Quality Assurance Complaints Representative to ensure compliance and investigation of product complaints. Candidates should have a Bachelor's degree in a related field and experience in a GMP facility. The role includes coordinating complaints investigations, supporting process improvement initiatives, and ensuring compliance during inspections. This position offers a competitive salary and comprehensive benefits.

Qualifications

• Experience in a GMP facility required.
• Proficiency with applicable computer systems required.

Responsibilities

• Coordinates complaints investigations for product batches.
• Mentors Operation and support personnel on quality matters.
• Supports internal and external regulatory inspections.
• Participates in Lean projects to improve productivity.

Skills

Quality Systems Management

Root Cause Analysis

Basic Communication Skills

Interpersonal Skills

Attention to Detail

Education

Bachelor's or equivalent degree in Science or Engineering

Tools

SAP

MES (PMX)

Darwin

Job description

Quality Assurance Complaints Representative

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 worldwide 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

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Position Brand Description

The Quality Assurance Complaints Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.

The QA Complaints Representative is responsible for coordinating and investigating complaints received by both internal and external customers associated with Incoming Materials, Semi‑Finished and / or Finished drug products. The QA Complaints Representative provides information related to complaints to process team members for non‑conformance investigations, issue resolution, and other process improvement activities.

Responsibilities

• Coordinates and performs complaints investigations received from internal / external customers associated with incoming materials, semi‑finished and/or finished drug product batches for Indianapolis Parenteral products, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market and complaints investigated thoroughly.
• Lead, Mentor and Coach Operation and support personnel on quality matters associated with the Complaints.
• Provide support during internal / external regulatory inspections.
• Participates in Lean project or process improvement initiatives to improve productivity within the Complaints work center and / or the site.
• Perform and / or lead detailed complaint investigations.
• Perform initial visual / physical examination of returned complaint samples.
• Monitor incoming product complaints for trends and incidents that may relate to a quality issue with product.
• Support Annual Product Review process, including complaint and Reference and Retention Sample evaluation.
• Support and or lead other investigation types including Trends, Inter‑Company Complaints, and Deviation.

Basic Qualifications

• Bachelors or equivalent (Science or Engineering related degree preferred).
• Demonstrated relevant experience in a GMP facility.

Additional Skills/Preferences

• Demonstrated relevant experience in a GMP facility.
• Proficiency with applicable computer systems.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to as a team.
• Root cause analysis / troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Previous experience with Lilly Complaint Management process.
• Proficiency with SAP, MES (PMX), and Darwin.
• Previous experience in QC, QA, Operations, TS/MS, Engineering or Regulatory is desirable.
• Technical Writing and Communication Skills.

Additional Information

• Overtime may be required.
• Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Position is located at the Lilly Technology Center - South.

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.

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.