Technician - Quality Assurance

Eli Lilly and Company•Carolina, PR

44d•$15 - $32

About The Position

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. Will monitor and approve cleanings for the manufacturing rooms and equipment and will serve as liaison between quality representatives and manufacturing area. This role will perform sampling of GMP equipment and/or utilities such as: water, compress air and environmental monitoring viable and non-viable, results entry (Darwin/MODA), and results review. Review data audit trails of the computerized systems that supports manufacturing operations and environmental monitoring of the site. Review of manufacturing batch record ensuring that the data integrity (DI) requirements for the operational process, computer systems and records used for the manufacturing of products are met. Will participate of the quality manufacturing meetings and the data integrity meetings and other process teams, when required. Will work closely with operations, TSMS, Quality DI Representative and Manufacturing Quality Assurance Representatives of the different areas. Main Responsibilities: This role will ensure compliance with cGMPs, Global Quality Standards and Good Documentation Practices, focusing on Data Integrity, Documentation review, Cleaning and manufacturing processes execution: Review, monitor, and approve major and minor cleanings (when required) of equipment and rooms. Perform sampling of "swab" and "Rodac" of equipment and rooms according to existing procedures. When required, approve areas for "Return to Service" after construction. Review batch record documentation to ensure all steps were executed as described in the manufacturing batch record and established standards. Ensure product meet with criteria and process parameters established. Review of the manufacturing and utilities computerized systems Data Audit Trails according to written instructions and training provided. These reviews help to assure that the electronic records meet all data integrity expectations. Escalate to the Quality Representatives, QA Supervision, and/or QA DI. Representative any discrepancy to meet cGMP controls and Data Integrity. Provide support on the execution of environmental monitoring procedures and evaluate if procedures need improvements, as needed. Execute water, compress air and environmental (microbiology) monitoring. • Provide feedback to the site for opportunities or concerns identified through documentation and audit trail review process. Support and abide 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. Comply with the requirements established in the Security Policy, Occupational Safety and Industrial Hygiene Policy, Standard Operational Procedures (SOPs) and Basic Safety Rules. 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. 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. At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Requirements

Bachelor’s degree in science, engineering or related field.
Minimum of 3 years of experience in GMP operations.
Understanding and working knowledge of domestic and international data integrity regulations and other policies/regulations as applicable.

Nice To Haves

Bilingual (English and Spanish).
Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.
Teamwork oriented.
Candidate must have a strong compliance mindset and sound judgment.
Establish effective interpersonal relationships.
Work variable periods of time (short and long).
Highly flexible, adapting to changes in priorities, requirements and processes is required.

Responsibilities

Review, monitor, and approve major and minor cleanings (when required) of equipment and rooms.
Perform sampling of "swab" and "Rodac" of equipment and rooms according to existing procedures.
When required, approve areas for "Return to Service" after construction.
Review batch record documentation to ensure all steps were executed as described in the manufacturing batch record and established standards.
Ensure product meet with criteria and process parameters established.
Review of the manufacturing and utilities computerized systems Data Audit Trails according to written instructions and training provided. These reviews help to assure that the electronic records meet all data integrity expectations.
Escalate to the Quality Representatives, QA Supervision, and/or QA DI. Representative any discrepancy to meet cGMP controls and Data Integrity.
Provide support on the execution of environmental monitoring procedures and evaluate if procedures need improvements, as needed.
Execute water, compress air and environmental (microbiology) monitoring.
Provide feedback to the site for opportunities or concerns identified through documentation and audit trail review process.
Support and abide 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.
Comply with the requirements established in the Security Policy, Occupational Safety and Industrial Hygiene Policy, Standard Operational Procedures (SOPs) and Basic Safety Rules.