Quality Control Validation Scientist

Katalyst CRO; Thousand Oaks (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading contract research organization in Thousand Oaks, California, is seeking an experienced professional for analytical method validation. The role demands at least 7 years of experience in analytical development within pharmaceutical settings, a strong understanding of regulatory standards, and proficiency in technical writing. Responsibilities include driving validation efforts, maintaining laboratory equipment, and supporting troubleshooting of analytical methods. Candidates should possess a Bachelor's degree in a relevant field. Competitive compensation and benefits package offered.

Qualifications

• Minimum of 7 years of experience in analytical development or validation.
• Experience in reviewing and approving Life Cycle Validation Documents.
• Familiar with commissioning, Installation, Operational and Performance Qualification protocols.

Responsibilities

• Drive analytical method validation and transfer laboratory methodologies.
• Ensure laboratory equipment maintains a validated state.
• Support troubleshooting of analytical methods.

Skills

Strong technical writing skills

Knowledge of analytical methods

Knowledge about analytical method validation

Intermediate statistical knowledge

Knowledge concerning cGMP

Basic regulatory requirements knowledge

Proficient in Microsoft Office

Strategically and business-oriented thinking

Education

Bachelor's degree in Biotechnology, Microbiology, Pharmacy, Chemistry

Tools

Paperless validation software

Microsoft Office

Job description

Responsibilities

• Drive analytical method validation/ transfer of laboratory methodologies.
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols.
• Support troubleshooting of analytical methods.
• Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products.
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• May support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.

Requirements

• Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
• Minimum of 7 years of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Nice to have the KNEAT Program, not required.
• Experienced in reviewing and approving Life Cycle Validation Documents including:
• Familiar with paperless validation software for life science.
• Commissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.
• Computer System Validation protocols and reports, including SCADA, MES.
• QC/Micro Laboratory Instrument Qualification and method validation.

Skills

• Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements.
• Knowledge of analytical methods and operations with strong emphasis in problem-solving.
• Knowledge about analytical method validation.
• Intermediate statistical knowledge and experience with data analysis.
• Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
• Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods.
• Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
• Proficient in Microsoft Office.
• Strategically and business-oriented thinking.