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 39,000 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.
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 sample retrieval activities per applicable local procedures, and is responsible for performing and/or verifying visual and/or functional evaluations of product complaint samples returned to Lilly. 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.
Minimum time in this position is three years.
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 sample 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 sample and perform product complaint sample retrieval actions per local procedures.
Perform and/or verify results of visual and/or functional analysis of returned complaint samples per local procedures
Assess product complaint information and the results of the returned complaint sample, 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 endeavors (e.g., request for batch number and/or product complaint sample).
Apply cGMP and cGLP principles in all phases of the product complaint investigation (e.g., data documentation).
Build and maintain working relationships with The Lilly Answers Center, manufacturing/packaging sites, and other affiliates associated with the Americas Regional Center.
Participate in new product design and pre-launch preparation projects to identify and address potential customer product complaints.
Contribute to post-launch product complaint monitoring activities.
Serve as a subject matter expert (SME) for applicable CPQA-ARC procedures and work instructions.
Participate in departmental process improvement activities.
Bachelor s Degree in health science related field (e.g., pharmacy, nursing, chemistry, biology, or engineering) and
A minimum of 1 year in healthcare professional experience (e.g., clincial pharmacy, nursing).
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Two years of regulated industry experience (e.g., exposure to cGMPs) with demonstrated knowledge of related quality systems.
Strong Lilly product knowledge relating to how products work medicinally and functionally.
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 relating to software used 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.
Experience writing requirements documents (e.g., procedures) & developing training materials.
Experience within the field of parenteral products, dry products, or devices.
The position does not require shift work or frequent traveling. The QA Associate will work in an office and/or laboratory environment. The job also requires that the successful candidate be mobile and able to frequently commute between office environments in multiple / separate buildings. Responsibility for after-hours and year-end holiday coverage may be required.
The associate may work in a laboratory environment with potential exposure to known allergens and the contents of returned product complaint samples.
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.