Senior QC Analyst: Method Development & Validation Lead

Croda Singapore; Alabaster (AL); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

PTO (paid time off)

401(k) match

Wellness reimbursement

Parental leave

Life and AD&D insurance

Disability insurance

Paid holidays

Job summary

Croda is seeking a Senior QC Analyst in the Alabaster, Alabama facility to lead analytical method development and validation for raw materials, in-process samples, and finished products. The role supports technology transfer, verification, and lifecycle maintenance under GMP and regulatory standards.

Responsibilities include executing validation studies for chemical, biochemical, and biological analyses, contributing to reports, and ensuring data integrity.

Qualifications

• Bachelor’s degree in a chemical/biological science required.
• 2–5 years in pharma/biotech GMP settings preferred.
• Experience with method validation, transfer, and regulatory alignment (ICH/USP/FDA).

Responsibilities

• Develop, validate, transfer, verify, and maintain analytical methods across materials and products.
• Lead method transfer activities between labs and external labs.
• Support audits, CAPAs, and data integrity during method development and validation.
• Collaborate with QC, QA, manufacturing, and external partners to ensure regulatory compliance.
• Maintain readiness for internal/external audits and documentation.

Skills

Analytical method development

Analytical method validation

Method transfer

ICH/USP/FDA regulatory standards

Data integrity

cGMP compliance

Statistical data analysis

Laboratory investigations

Problem solving

Education

Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Analytical Chemistry, or related field

Tools

LIMS

Chromatography data systems

Job description

Croda is seeking a Senior QC Analyst in the Alabaster, Alabama facility to lead analytical method development and validation for raw materials, in-process samples, and finished products. The role supports technology transfer, verification, and lifecycle maintenance under GMP and regulatory standards.

Responsibilities include executing validation studies for chemical, biochemical, and biological analyses, contributing to reports, and ensuring data integrity.