Hybrid Associate - Quality Assurance, Complaints Investigator bei Lilly

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.

Overview:

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.  

Responsibilities: 
•    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 pharmaceutical investigations 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.

Basic Requirements: 
•   A bachelor’s degree in nursing or pharmacy with a minimum of 2 years of experience

-or-

•   A bachelor’s degree in health science related field (e.g., chemistry, biology, or engineering) with at least 2 years of industry complaint-specific experience

Additional Preferences: 
•    A health care professional background (e.g., degree in pharmacy or nursing).

•    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).

•   Demonstrated knowledge of related quality systems

•    Experience within the field of devices or parenteral products.

•    Regulated industry experience (e.g., exposure to cGMPs), preferably in quality organizations

Additional Information: 
•    The position does not require shift work or frequent traveling.  
•    Responsibility for after-hours and company shutdown coverage may be required.
•    The QA Associate will work in an office and/or laboratory environment. 
•    The associate will work in a laboratory environment with potential exposure to known allergens, oncolytics, and the contents of returned complaint product.

This position is not remote and is based in Indianapolis, IN, requiring time onsite.

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 - $140,800

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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