Lilly Complaint Investigator - Quality Assurance in Indianapolis, Indiana
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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description:
The CPQA-ARC Quality Assurance (QA) Associate Complaint Investigator (hereafter referred to as QA Associate) is responsible for evaluating product complaint record information to determine the: validity of the complaint; complaint level; complaint category(ies); investigation site and; where appropriate, complaint conclusions. The QA Associate is responsible for performing batch number and/or product retrieval activities per applicable local procedures. The QA Associate may also be responsible for performing and/or verifying visual and/or functional evaluations of returned complaint product and determining the appropriate triage of the returned product. The QA Associate is responsible for determining any follow up information required from the reporter or related contacts that may assist with the triage of the complaint record.
Assess product complaint information, designate an appropriate complaint level, and assign suitable complaint and/or analysis category(ies).
Determine the need for additional investigation and forward product complaint records and/or complaint product to the proper manufacturing or packaging quality unit for further investigation, as required.
Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from the reporter and/or related parties.
Determine the need for the product complaint return and perform complaint product retrieval actions, per local procedures.
Perform visual and/or functional analysis of returned complaint product, per local procedures.
Assess product complaint information and the results of the returned complaint product, including impact on: complaint level; complaint category(ies); investigating site; and additional investigation requirements.
Respond to the customer with educational information, as applicable, during customer follow up activities (e.g., request for batch number and/or product complaint sample).
Forward process complaints and related activities in adherence to established timeframes
Apply cGMP principles in all phases of the product complaint investigation (e.g., data documentation).
Perform CPQA laboratory related tasks (e.g. returned product check-in, product shipping, waste drum disposal), as applicable.
Build and maintain working relationships with The Lilly Answers Center and other affiliates associated with the Americas Regional Center, as well as manufacturing and packaging sites, global product protection technical team, global patient safety, and other regional complaint centers.
Serve as a subject matter expert (SME) for applicable CPQA-ARC procedures and work instructions.
Participate in departmental process improvement activities.
Conduct training and peer monitoring, as applicable.
Maintain appropriate training qualification to perform complaint investigation activities.
Solid collaboration, teamwork and interpersonal skills.
Strong verbal and written communication skills in English.
Attention to detail.
Self-management / motivated.
Ability to multi-task.
Above average computer literacy and computer skills. Specific training for complaint handling software will be provided.
Strong curiosity skills with the ability to question/identify issues & work to resolution.
Strong critical thinking/problem solving skills with an ability to apply rationale.
Ability to mentor/train others - share learning.
Ability to safely work in a laboratory environment (e.g. wear appropriate personal protection, potential for exposure to allergens, able to lift 20 pounds).
- A Bachelor’s degree in health science related field (e.g., pharmacy, nursing, chemistry, biology, or engineering).
A health care professional background (e.g., degree in pharmacy or nursing).
3 + years of relevant product complaint experience.
2 years of regulated industry experience (e.g., exposure to cGMPs) with demonstrated knowledge of related quality systems.
Experience within the field of devices or parenteral products.
The position does not require shift work or frequent traveling.
Responsibility for after-hours and year-end holiday coverage may be required.
The QA Associate will work in an office and/or laboratory environment.
The associate may work in a laboratory environment with potential exposure to known allergens, oncolytics, and the contents of returned complaint product.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!