Lilly Jobs

Job Information

Lilly Sr. Quality Assurance Technician in Carolina, Puerto Rico

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 35,000 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.

Job Description:

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 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 utilities such as: water, compress air and environmental monitoring viable and non-viable, results entry (Darwin/ MODA), and results review. Will participate of the quality manufacturing meetings and the data integrity meetings and other process teams, when required. Will work closely with operations, Quality DI Representative and Manufacturing Quality Assurance Representatives of the different areas.

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 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.

  • 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.

  • Participate in the strategies definition, revisions and recommendations of validation protocols.

  • 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

Basic Requirements:

• Bachelor’s degree or higher in the sciences, engineering, or related field. (or equivalent work experience)

• 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

• Language (English and Spanish)

Additional Skills/Preferences:

• 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.

• Establish positive interpersonal relationships and interact effectively with people.

• Work variable periods of time (short and long).

• Highly flexible, adapting to changes in priorities, requirements and processes is required.

• Execute with safety first and quality always.

Additional Information:

• Rotating shift mainly 1st and 2nd. Available to work on weekends and after regular hours, as deemed necessary.

• Carolina, PR1 site.

• This position is not permanent. It is for a fixed term position up to a maximum of 3 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 ( LillyRecruitingCompliance@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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

#WeAreLilly

DirectEmployers