Quality Control Chemist - Regulated Lab & Data Integrity

BioSpace; Tampa (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

Eagle Analytical seeks a Quality Control Chemist to oversee analytical chemistry documentation and quality records, ensuring regulatory compliance across cGMP, cGLP, ISO 17025, A2LA, and USP standards.

You will review methods, validation documentation, lab data, and investigations while collaborating with operations to uphold data integrity and drive continuous improvement in chemistry testing.

Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, or related field.
• Experience in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
• Experience supporting analytical chemistry testing laboratories preferred.
• Strong understanding of analytical techniques and instrumentation (HPLC, HPLC-MS/MS, GC-MS, UV-Vis).
• Working knowledge of method validation, data review, and quality systems.

Responsibilities

• Ensure compliance with SOPs and Quality Management System.
• Interpret ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
• Support regulatory inspections, client audits, and accreditations.
• Write, review, and approve SOPs, forms, and quality records.
• Review analytical test methods and related documentation for chemistry testing.
• Review lab test reports, logs, and validation documents.
• Ensure data integrity, accuracy, and traceability.
• Review and approve quality investigations and CAPA.
• Conduct internal audits of quality systems.
• Perform walk-through audits across departments.
• Maintain quality documentation storage and quarantine materials.
• Prepare and maintain training materials.

Skills

Attention to detail

Data integrity

Communication skills

Independent worker

Cross-functional collaboration

MS Office

Electronic docs

Education

Chemistry degree

Biochemistry degree

Tools

HPLC

HPLC-MS/MS

GC-MS

UV-Vis

Job description

Eagle Analytical seeks a Quality Control Chemist to oversee analytical chemistry documentation and quality records, ensuring regulatory compliance across cGMP, cGLP, ISO 17025, A2LA, and USP standards.

You will review methods, validation documentation, lab data, and investigations while collaborating with operations to uphold data integrity and drive continuous improvement in chemistry testing.