Quality Control Validation Scientist

Katalyst CRO; Thousand Oaks (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in Thousand Oaks, CA invites a senior analytical development professional to drive method validation and transfer across laboratory methodologies. The role emphasizes problem solving, regulatory compliance, and high-quality technical documentation.

The candidate will support execution of test plans, instrument qualification, and data analysis, leveraging cGMP knowledge and statistical methods to ensure validated methods meet quality standards for biopharmaceutical manufacturing.

Qualifications

• Bachelor's degree in biotechnology, microbiology, pharmacy, chemistry or equivalent.
• Minimum of 7 years of analytical development/validation experience in pharma/biopharma or related manufacturing.
• Knowledge of Life Cycle Validation documents and CGMP standards.
• Experience with paperless validation software for life science.
• Familiar with Commissioning, IQ/OQ/PQ protocols and reports for equipment/facilities/utilities.
• Knowledge of computer system validation (SCADA, MES).
• Knowledge of QC/micro lab instrument qualification and method validation.

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.

Skills

Analytical method validation

Transfer of laboratory methodologies

Statistical data analysis

Technical writing

cGMP knowledge

Regulatory compliance

Problem solving

Strategic thinking

Education

Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent

Advanced degree (preferred)

Tools

SCADA

MES

Validation software

Job description

• 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.

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.