Quality Control Chemist I – Precision Analytics

Regulatory Toolkit; Jayuya (PR); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage

Day-one benefits

ESPP program

401(k) with company match

Résumé du poste

Baxter's Quality Control Laboratory seeks a Chemist I to join the team. You will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory to ensure product quality, compliance, and patient safety through testing of raw materials, in-process samples, water systems, and finished products.

The role requires a Chemistry degree and 3–5 years of pharma QC experience, with hands-on analytical instrumentation and strong data integrity practices.

Qualifications

• Bachelor's Degree in Chemistry or related field.
• 3–5 years of laboratory experience in a pharmaceutical, biotechnology, medical device, or regulated manufacturing environment preferred.
• Experience performing analytical and chemical testing within a Quality Control laboratory.
• Working knowledge of pharmaceutical laboratory practices and regulatory requirements.
• Hands-on experience with analytical instrumentation, including: HPLC, UV/Vis, pH meters, IR, AA, Karl Fischer, TOC Analyzers, Polarimeters
• Ability to perform statistical data analysis and interpret laboratory results.
• Fully bilingual in English and Spanish, with the ability to read, write, understand, and communicate effectively in both languages.

Responsabilités

• Perform chemical analyses of raw materials, in-process samples, water systems, intermediates, and finished products in accordance with approved methods and specifications.
• Execute specialized analytical testing using laboratory instrumentation, including HPLC, UV/Vis Spectrophotometry, pH Meters, IR, Atomic Absorption, Karl Fischer, TOC Analyzer, Polarimeter, and related equipment.
• Evaluate test results against established product specifications and make sound analytical assessments to support product quality decisions.
• Perform analytical data review to ensure accuracy, completeness, and compliance with regulatory requirements.
• Follow current Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), and Good Laboratory Practices (cGLP) in all laboratory activities.
• Maintain data integrity and ensure accurate, complete, and timely documentation of all testing activities.
• Support laboratory investigations, including Phase I investigations, and assist with Phase II investigations as needed.
• Monitor and maintain laboratory investigations through completion, ensuring compliance with quality standards and procedures.
• Audit laboratory procedures, retests, additional testing activities, and Standard Operating Procedures (SOPs).
• Perform routine maintenance, troubleshooting, calibration, and verification of laboratory equipment.
• Monitor laboratory environmental conditions, including temperature, humidity, and charting systems, to ensure compliance and operational readiness.
• Prepare reagents, standards, solutions, and materials required to support laboratory testing activities.
• Maintain laboratory readiness by ensuring workspaces are clean, sanitized, organized, and audit-ready at all times.
• Initiate and support improvements to analytical methods, laboratory procedures, and testing processes.
• Assist in the development, implementation, and validation of new or revised chemical testing procedures.
• Perform statistical evaluations and trending of analytical data to support process and quality improvements.
• Prepare weekly, monthly, quarterly, and annual laboratory reports as required.

Connaissances

HPLC

UV/Vis

pH Meters

IR Spectroscopy

Atomic Absorption

Karl Fischer

TOC Analyzers

Polarimeter

Statistical analysis

Bilingual EN/ES

cGMP knowledge

Formation

Bachelor's Degree in Chemistry

Outils

HPLC

UV/Vis

IR

AA

Karl Fischer

TOC Analyzer

Titration

Polarimeter

Analytical instrumentation

Description du poste

Baxter's Quality Control Laboratory seeks a Chemist I to join the team. You will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory to ensure product quality, compliance, and patient safety through testing of raw materials, in-process samples, water systems, and finished products.

The role requires a Chemistry degree and 3–5 years of pharma QC experience, with hands-on analytical instrumentation and strong data integrity practices.