Job Description

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. Were looking for people who are determined to make life better for people around the world.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the global 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.

Responsibilities:

The Quality representative works within the Lilly Branchburg QA Inspection team and will perform the following: incoming inspections including ID testing, sampling and release of raw materials/GMP supplies utilizing SAP and LIMS systems, inspections of bulk and final containers, finished goods, deliver samples to laboratories, and maintain retention samples. Technicians must be able to lift items up to 50 pounds. Ensures area of responsibility remains inspection ready and may provide assistance during regulatory/GMP inspections.

Day-to-day activities include:

* Incoming raw material and GMP supply inspections and releases according to their priority

* Documents physical inspections in accordance with procedures and specifications

* Releases, rejects, quarantines raw materials per local procedures

* Sampling, LIMS sample generation, SAP material classification, entering material disposition transactions in SAP and LIMS

* Raman ID testing of materials; Maintains raw material retains and samples per local procedures

* Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule

* Authors SOPs, materials specifications as needed; Conducts gap assessments between local procedures and governing global standards. Implements changes as needed to ensure regulatory and global standard compliance.

* Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.

* Leads scheduling activities for environmental monitoring of QA Sampling Suite

* Interacts with other quality functions and supports material related Supplier Change Notifications (SCN)

* Raw material and cell bank batch releases in LIMS and is the Raman SME for all raw material identification testing

* Participates in/supports regulatory inspections, as needed

* Provide Quality support to other areas such as document control, as necessary

* Abides by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined

Basic Qualifications:

* Minimum High school diploma, BA/BS degree in the sciences preferred

* Minimum of 1 year of relevant experience in the Biopharmaceutical Industry or previous technical experience should be related to area of responsibility, as appropriate

* 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.

Additional Preferences:

* Must support 24/7 days a week operation

* Must be able to lift up to 50 lbs

* Demonstrated understanding of cGMP regulations related to QA Inspection applications.

* Strong attention to detail

* Proficient in computer system applications

* Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands

* Understanding of statistical tools and analysis

* Excellent interpersonal and networking skills

* Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others

Additional Information:

* This position is not permanent. It is for a fixed term position up to a maximum of 4 years.

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 ( Lilly_Recruiting_Compliance@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.