Quality Assurance Technician

Jobtailor; Carolina (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Lilly is seeking a Quality Assurance professional to support GMP operations and environmental monitoring across manufacturing areas. You will review batch records, data trails, and cleaning approvals, acting as a liaison between quality and production teams.

The role requires a science/engineering degree with at least 3 years in GMP, plus bilingual English/Spanish preferred. Candidates should be flexible for shifts and travel as needed.

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Minimum of 3 years in GMP operations.
• Understanding of domestic and international data-integrity regulations.
• Bilingual English and Spanish preferred.

Responsibilities

• Monitor and approve cleanings for manufacturing rooms and equipment.
• Serve as liaison between quality representatives and manufacturing areas.
• Perform GMP equipment and utilities sampling (water, compressed air, and environmental).
• Enter and review results in Darwin/MODA.
• Review data audit trails supporting manufacturing operations and environmental monitoring.
• Review manufacturing batch records for data-integrity compliance.
• Participate in quality manufacturing, data integrity, and other process-team meetings.
• Review, monitor, and approve major and minor equipment and room cleanings.
• Perform swab and Rodac sampling methods.

Skills

GMP Operations

Data Integrity

Environmental Monitoring

Quality Assurance

Bilingual English/Spanish

Independent Planning

Interpersonal Skills

Adaptability

Education

Bachelor’s degree in science/engineering

Tools

Darwin

MODA

Job description

• Monitor and approve cleanings for manufacturing rooms and equipment
• Serve as liaison between quality representatives and manufacturing areas
• Perform GMP equipment and utilities sampling, including water, compressed air, and viable/non-viable environmental monitoring
• Enter and review results in Darwin/MODA
• Review computerized-system data audit trails supporting manufacturing operations and environmental monitoring
• Review manufacturing batch records for data-integrity compliance
• Participate in quality manufacturing, data integrity, and other process-team meetings
• Review, monitor, and approve major and minor equipment and room cleanings
• Perform equipment and room sampling using swab and Rodac methods
• Approve areas for return to service after construction when required
• Verify batch-record execution, product criteria, and process parameters
• Escalate cGMP and data-integrity discrepancies to quality representatives and QA supervision
• Support environmental-monitoring procedures and identify opportunities for improvement
• Provide site feedback from documentation and audit-trail reviews
• Support and follow Lilly policies, cGMPs, Global Quality Standards, Good Documentation Practices, SOPs, security, safety, and industrial-hygiene requirements

Requirements

• Bachelor’s degree in science, engineering, or a related field
• Minimum of 3 years of experience in GMP operations
• Understanding and working knowledge of domestic and international data-integrity regulations and applicable policies/regulations
• Bilingual English and Spanish preferred
• Demonstrated proficiency in planning and carrying out tasks independently and in a team environment
• Strong compliance mindset and sound judgment
• Ability to establish effective interpersonal relationships
• Ability to work variable periods of time, including short and long periods
• High flexibility and ability to adapt to changing priorities, requirements, and processes
• Availability for flexible schedules, irregular hours, weekends, holidays, rotating shifts, nights, and call‑ins
• Availability to support operational needs in rotating shifts
• Qualified applicants must be authorized to work in the United States full‑time; Lilly will not sponsor work authorization or visas

Core Competencies

Demonstrates expertise in GMP operations, data integrity compliance, and environmental monitoring procedures. Proficient in reviewing and approving manufacturing processes while ensuring adherence to quality standards and regulations.

Highest-signal resume keywords

• GMP Operations
• Data Integrity Compliance
• Environmental Monitoring
• Quality Assurance
• Bilingual English and Spanish

ATS Optimization Keywords

Hard Skills

• GMP Equipment Sampling
• Environmental Monitoring Procedures
• Data Audit Trail Review
• Manufacturing Batch Record Review
• Swab and Rodac Sampling Methods

Soft Skills

• Interpersonal Relationship Building
• Independent Task Planning
• Adaptability to Changing Priorities
• Strong Compliance Mindset
• Sound Judgment

Industry Keywords

• CGMP
• Good Documentation Practices
• Global Quality Standards
• SOPs
• Industrial Hygiene

Tools & Technologies

• Darwin
• MODA