Senior QC Scientist – Method Validation & Compliance

Orano; Plano (TX); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive compensation

Health, dental, and vision insurance

401(k) with employer matching

Life insurance

Generous paid time off

Training and development opportunities

Job summary

Orano in Plano, TX is seeking a Quality Scientist to ensure the integrity and compliance of analytical methods used in drug testing. This role partners with various teams, driving method qualification and validation while addressing compliance with FDA, EMA, and global regulations.

The ideal candidate will possess a Bachelor’s degree in Chemistry and have over 7 years of experience in the pharmaceutical industry, including technical review and QC analysis. Benefits include competitive compensation, health insurance, and 401(k) matching.

Qualifications

• 7+ years experience in the pharmaceutical industry.
• 5+ years experience as a QC analyst or Method Development professional.

Responsibilities

• Perform technical review of QC analytical data.
• Lead analytical method qualification and validation.
• Drive continuous improvement in method performance.
• Conduct investigations of analytical deviations.
• Provide technical review and approval of method transfer packages.
• Assess manufacturing processes for identification of risks.
• Execute quality and analytical tasks consistently.

Skills

Technical review of analytical data

Writing SOPs and technical reports

Knowledge of cGMP and FDA regulations

Proficient in Microsoft Office

Strong organization skills

Attention to detail

Ability to manage multiple projects

Education

Bachelor’s of Science in Chemistry or related field

Job description

Orano in Plano, TX is seeking a Quality Scientist to ensure the integrity and compliance of analytical methods used in drug testing. This role partners with various teams, driving method qualification and validation while addressing compliance with FDA, EMA, and global regulations.

The ideal candidate will possess a Bachelor’s degree in Chemistry and have over 7 years of experience in the pharmaceutical industry, including technical review and QC analysis. Benefits include competitive compensation, health insurance, and 401(k) matching.