QA Associate - Complaints IDAP

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.Organization Overview:Perform complaint investigations for IDAP packaging and manufacturing complaints for prefilled devices and drug/device combination products, drug/device combination products, dry products, and parenteral products.Responsibilities:

Perform complaint investigations for IDAP packaging and manufacturing complaints for prefilled devices and drug/device combination products, drug/device combination products, and parenteral products.

Support and initiate TW Trend, RCI’s, Tasks or other technical investigations, as applicable.

Perform quarterly trend analysis and investigations on product and process performance.

Compile and document monthly metrics/quarterly metrics/ad-hoc reports.

Understand the devices/combination products/parenteral packaging processes to support investigations as defined in PDS-SOP-PDS4153, Trending Complaint Data and associated complaint handling procedures (PDS-SOP-PDS4087 / PDS-SOP-PDS0042).

Collaborate and provide customer service for groups external to IDM, including, but not limited to, Regional Centers, AZ, OUS Affiliates, Global Patient Safety, SECI Quality, CPQA, DPEM, and component suppliers (e.g., Nypro, Nemera) as needed.

Support continuous improvement projects and new launches as applicable.

Compile and present complaint data for process teams,Site Lead Team, and Process Flow team.

Complete the eAPR complaints sections for each required product including compiling/summarizing data and presentation support as necessary.

Mentor and coach other QA Associates, as applicable.

Basic Requirements:

Minimum of three years industry experience in areas which may include Quality, MS&T, LRL, Development or Manufacturing/Packaging.

Technical knowledge in design, manufacturing or validation; preferably devices.

Technical knowledge of complaint handling and/or quality systems; preferably device packaging/assembly.

Knowledge of regulatory requirements (e.g., cGMP, 21 CFR 820, ISO13485, Canadian MDR).

Strong computer literacy in Outlook and Microsoft.

Must be able to handle returned complaint samples requiring execution of universal precautions and medical surveillance panel.

Additional Skills/Preferences:

Basic knowledge in statistics and its applications.

Ability to compile data and metrics in reports understandable by management and business partners.

Attention to detail; self-management; problem solving; mentoring.

Bachelor’s degree in engineering, Medical or Life Sciences or equivalent experience preferred.

Additional Information: Travel less than 10% Monday - Friday daysLilly 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 - $162,800Full-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