Analytical Validation & QC Systems Scientist

Avara Pharmaceutical Services; Arecibo (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Avara Pharmaceutical Services is seeking an Analytical Technology lead to support Quality Control during new product introductions. The role covers method development, validation, transfer and instrument service, ensuring QC systems comply with FDA/cGMP and GAMP standards.

The incumbent will collaborate across departments, manage validation documentation, and guide improvements to laboratory processes and electronic systems.

Qualifications

• Bachelor's degree in science, engineering or computer science from an accredited institution.
• At least five (5) years of laboratory experience or systems validation in an FDA regulated environment.
• CSQE certification preferred.
• Chemical Licensee preferred.

Responsibilities

• Collaborate with functional areas to determine regulatory requirements and validation deliverables.
• Generate, review and approve validation/automation documentation and SOPs.
• Coordinate validation of laboratory equipment, facilities, utilities and software per FDA, cGMP and GAMP guidelines.
• Perform method development, validation, transfer and verification for products.
• Support CAPA, change control and incident resolution to improve laboratory processes.

Skills

Regulatory compliance

Project management

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor's degree in Science/Engineering/CS

Tools

LIMS Vantage

LIMS Lab Ware

CDMS Empower

HPLC

UPLC

GC

FTIR

NIR

Dissolution Bath

KF

Job description

Avara Pharmaceutical Services is seeking an Analytical Technology lead to support Quality Control during new product introductions. The role covers method development, validation, transfer and instrument service, ensuring QC systems comply with FDA/cGMP and GAMP standards.

The incumbent will collaborate across departments, manage validation documentation, and guide improvements to laboratory processes and electronic systems.