Technician-QA Sampling Monitoring

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.

Patients are at the center of everything we do at Lilly. We are currently hiring a Technician QA

This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. #WeAreLilly

Responsibilities

Sampling Collection & Environmental Monitoring

• Perform the samples collection and quality monitoring oversight of the PR05 Utilities Systems (e.g., , compressed gasses) and the Environmental Monitoring Program (e.g., room air – viable and non-viable, contact plate).
• Assure timely samples collections as established in the corresponding sampling plan or protocol in compliance with applicable procedure requirements.
• Support the Quality Assurance (QA) oversight of the Site Utilities Systems and Environmental Monitoring results.
• Support the generation of the systems performance/routine reports.
• Corresponding coordination with impacted areas such as: laboratory, utilities, operations, etc.
• Appropriate use of applicable equipment for samples collection and delivery.
• Assure appropriate aseptic techniques.
• Assure timely approval and reporting of applicable Sampling results.
• Appropriate documentation management complying with corresponding requirements.

Quality Oversight & Compliance

• Provide Quality Assurance oversight to Good Manufacturing Practices (GMP) operations.
• Adhere to standard operating procedures and current Good Manufacturing Practices.
• Serves as reviewer of Good Manufacturing Practices (GMP) and Quality related Standard Operational Procedures (SOP’s), as applicable.
• Provides Quality Assurance (QA) assistance and feedback to utilities and operational staff.

Inspection Readiness and Continuous Improvement

• Support the execution of the applicable inspection readiness activities including the participation of self-inspection activities when required.
• Maintain and suggest improvements to the Quality Systems.
• Participate on quality improvement projects when required.
• Escalate quality issues to the site-based process team.

Educational Requirements

• Associate degree in a science, engineering, or pharmaceutical related field as a minimum.

Experience Requirements

• From entry-level to three (3) years of experience in a GMP and FDA regulated environment in roles such as:

• Quality Assurance
• Quality Control Laboratory
• Manufacturing
• Technical Services

• Establish positive interpersonal relationships and effectively interact with people and departments internally and externally.
• Organize and prioritize multi-functional tasks.
• Memorize details and ideas.
• Work under time and schedule pressure.
• Exercise good judgment and be assertive when required.
• Work under minimal supervision.
• Communicate at all levels.
• Excellent decision-making.
• Proficiency with computer systems such as: Microsoft Office, TrackWise, SAP, DARWIN, Veeva Quality Docs, Building Management Systems (BMS), and other Quality Systems platforms.
• Knowledge and application of Good Documentation Practices (GDP) and data integrity principles.
• Capability to perform and evaluate Aseptic Techniques.
• Ability to travel within and outside Puerto Rico and the United States as needed.
• Flexibility to support a 24/7 operation, including irregular hours, shift rotations, weekends, holidays, and emergencies.
• Capability to work as a resource in other business areas depending on operational needs.
• Demonstrate teamwork by collaborating cross‑functionally at all organizational levels.
• Support continuous improvement initiatives and drive productive working relationships.
• Bilingual (English and Spanish) with strong verbal and written communication skills.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law.Marijuana is considered unauthorized by Lilly.

"Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

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

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.

#WeAreLilly