Analytical QC Validation Scientist

USDM Life Sciences; Thousand Oaks (CA); On-site; USD 90,000 - 103,000; Full time

Job summary

USDM Life Sciences in Thousand Oaks, CA is seeking a QC Analytical Scientist to support analytical method validation, transfer, and execution in a cGMP environment within the AQC department.

You will generate technical documents, apply statistics, troubleshoot methods, maintain validated equipment, and ensure timely deliverables while adhering to regulatory standards such as CGMP, USP, ICH.

Qualifications

• Bachelor's degree in biotechnology, microbiology, pharmacy, chemistry or equivalent.
• At least 1 year of analytical development or validation experience in pharmaceutical/biopharmaceutical manufacturing.
• Experience with cGMP and regulatory requirements for analytical testing.

Responsibilities

• Drive analytical method validation and transfer of laboratory methodologies.
• Support execution and issue resolution of test plans/protocols.
• Support troubleshooting of analytical methods.
• Ensure laboratory equipment is maintained in a validated state and that transfers follow regulatory requirements.
• Prepare protocols, reports and other technical documents as required.
• Use statistical techniques to solve problems and make recommendations.
• Support IOQ, maintenance and troubleshooting of instrumentation in AQC.
• Ensure deliverables meet timelines and milestones.
• Other duties as assigned.

Skills

Technical writing

Analytical methods

Analytical method validation

Data analysis

Statistical techniques

cGMP knowledge

Regulatory requirements

Instrument/regulatory knowledge

Regulatory standards

Project management

Multi-tasking

Attention to detail

Microsoft Office

Strategic thinking

Education

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

Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree

Tools

SCADA

MES

Job description

USDM Life Sciences in Thousand Oaks, CA is seeking a QC Analytical Scientist to support analytical method validation, transfer, and execution in a cGMP environment within the AQC department.

You will generate technical documents, apply statistics, troubleshoot methods, maintain validated equipment, and ensure timely deliverables while adhering to regulatory standards such as CGMP, USP, ICH.