Technician - QC Laboratory

Lilly del Caribe • Carolina, PR

2d • Onsite

About The Position

This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. The QC Analyst – Finished Product performs chemical testing and analysis on finished pharmaceutical products from manufacturing dry product, stability, and in-process (cleaning valuations) for quality control areas. This role executes analytical methods in strict adherence to SOPs, pharmacopeial standards (USP/EP/BP), and GMP requirements. The position also verifies data integrity of laboratory samples, supports method validation activities, equipment qualification, and analytical method transfers to ensure product safety, efficacy, and regulatory compliance.

Requirements

• Bachelor’s degree in chemistry, or related natural science
• Minimum 1 year of relevant pharmaceutical or quality control laboratory experience
• Proficiency with analytical instrumentation – including but not limited to: Chromatography techniques: HPLC, UPLC, or GC; Spectroscopy: UV-Vis, FTIR or NIR; Physical testing equipment: Analytical balances, microbalances, dissolution apparatus; TOC (Total Organic Carbon) analyzers
• Familiarity with additional instruments (e.g., Karl Fischer titration, particle size analysis)
• Strong understanding of laboratory analysis best practices including: Wet chemistry and quantitative analysis techniques; Proper sample preparation and handling procedures; Method validation principles and execution (ICH guidelines); Data integrity and regulatory compliance (21 CFR Part 11, ALCOA+ principles)
• Demonstrated knowledge of pharmaceutical regulations and standards: FDA regulations (21 CFR Parts 210-211, GMP requirements); Pharmacopeial standards (USP, EP, or BP); ICH Quality Guidelines
• Strong analytical thinking and attention to detail with ability to troubleshoot analytical problems
• Proficiency in laboratory information management systems (LIMS) – or demonstrated ability to quickly learn proprietary systems
• Excellent written and verbal communication skills – able to clearly document results and present findings
• Ability to work independently and as part of a cross-functional team
• Commitment to quality and GMP compliance mindset
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Nice To Haves

• Experience with finished dosage form testing and/or pharmaceutical product analysis is strongly preferred
• Experience in a GMP-regulated environment preferred
• Bilingual proficiency in English and Spanish – written and verbal Preferred for technical documentation, safety communications, and team collaboration in bilingual environments
• Problem-solving skills with ability to conduct root cause analysis and implement corrective actions
• Experience with method validation or analytical method transfer projects.
• Familiarity with statistical analysis tools or software (Empower, or equivalent)
• Certified Quality Analyst (CQA) or pursuit of analytical chemistry certification
• Demonstrated experience with process improvement or continuous quality initiatives
• Knowledge of automation tools or robotics in laboratory settings
• Experience with laboratory safety and environmental compliance programs
• Familiarity with Good Laboratory Practice (GLP) standards
• Background in stability testing protocols and long-term storage studies

Responsibilities

• Perform chemical testing and analysis on finished pharmaceutical products from manufacturing dry product, stability, and in-process (cleaning valuations) for quality control areas.
• Execute analytical methods in strict adherence to SOPs, pharmacopeial standards (USP/EP/BP), and GMP requirements.
• Verify data integrity of laboratory samples.
• Support method validation activities, equipment qualification, and analytical method transfers to ensure product safety, efficacy, and regulatory compliance.
• Provide technical support to operations 24/7 as needed.
• Manage multiple priorities in a fast-paced, regulated environment while maintaining accuracy.
• Conduct root cause analysis and implement corrective actions.
• Participate in regulatory inspections, audit preparation, or quality investigations.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• 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: Entry Level