Senior Analytical Quality Scientist – GMP Method Validation

Orano Med, LLC.; Plano (TX); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401(k) with employer match

Life insurance

Short- and Long-Term Disability

Paid Time Off

Training and Development opportunities

Job summary

Orano Med LLC in Plano, TX, is seeking a Quality Scientist to ensure the integrity and regulatory compliance of analytical methods for drug product testing from development through Phase 2 manufacturing. You will lead investigations, CAPAs, method qualification, validation, and transfer in line with FDA/EMA guidelines.

The role requires strong GMP knowledge, meticulous data translation, and collaboration with QC, Analytical Development, Manufacturing, and QA teams to deliver robust data and

Qualifications

• Bachelor's of Science (or higher) in Chemistry or related field.
• 7+ years experience in Pharmaceuticals.
• 5+ years experience as a QC analyst or Method Development.

Responsibilities

• Perform technical review of QC analytical data and reports to verify accuracy and data integrity.
• Lead analytical method qualification, validation, and transfer activities per ICH Q2/Q14, FDA/EMA guidelines.
• Drive improvement of qualification/validation programs through data trending and method performance monitoring.
• Investigate deviations, OOS/OOT results, and nonconformances with robust root cause analysis and CAPA.
• Provide technical review and approval of method transfer packages and validation documents.
• Assess manufacturing processes and R&D recommendations to identify risks and support optimization.
• Execute complex quality and analytical tasks to deliver high-quality data, methods, and processes.
• Perform additional duties to advance quality system maturity and regulatory compliance.

Skills

Analytical method review

GMP compliance

Regulatory knowledge

Data interpretation

Education

Bachelor's degree in Chemistry or related field

Job description

Orano Med LLC in Plano, TX, is seeking a Quality Scientist to ensure the integrity and regulatory compliance of analytical methods for drug product testing from development through Phase 2 manufacturing. You will lead investigations, CAPAs, method qualification, validation, and transfer in line with FDA/EMA guidelines.

The role requires strong GMP knowledge, meticulous data translation, and collaboration with QC, Analytical Development, Manufacturing, and QA teams to deliver robust data and