Technician - Quality Assurance

Eli Lilly and Company • Carolina, PR

2d • $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.

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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees