Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $15.21 - $31.85Job Scope: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 support 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 products 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 ensure 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 improvement, 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 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. Additional Skills/Preferences:•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. Additional Information:•Available to support operation needs in rotating shifts.•Available to work on weekends and after regular hours, as deemed necessary.•This is a fixed term position.