Senior QC Analytical Scientist - Method Development

USDM Life Sciences; Thousand Oaks (CA); On-site; USD 69,000 - 83,000; Full time

Job summary

USDM Life Sciences is seeking a QC Analytical Scientist II to support Analytical Quality Control (AQC) activities. You will transfer and execute analytical methods for CGMP environments, including QC microbiology, collaborating across teams to ensure quality and compliance.

The role emphasizes method development/validation, instrument qualification, investigations, and data analysis. A Bachelor’s degree is required with 3+ years in analytical development or validation in GMP settings, with

Qualifications

• Excellent technical writing skills and able to write technical documents and reports that meet company and regulatory requirements.
• In depth knowledge of analytical methods and operations with strong emphasis in problem-solving.
• Knowledge about analytical method validation and critical reagent qualification.
• 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, test methods and licenses.
• Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
• Ability to complete tasks with minimal direction, demonstration of basic project management skills.
• Ability to multi-task in a highly dynamic and diverse environment.
• Attention to detail, good organization, and time management skills to meet deadlines.
• Proficient in Microsoft Office.
• Strategic and business-oriented thinking.

Responsibilities

• Drive special projects that require AQC attention/leadership.
• Drive analytical method development and validation of laboratory methodologies and instrumentation, including leading QC efforts for new product testing.
• Support investigations and manufacturing investigations requiring analytical method support.
• Support installation, qualification, maintenance and troubleshooting of instrumentation in AQC.
• Lead teams on projects and interact with other group functions.
• Upgrade analytical technologies within an established licensed technology platform.
• Support execution and resolution of test plans/protocols and associated documentation.
• Assist with iOOS, OOT, and atypical result investigations as needed.
• Review and approve laboratory investigations, deviations, CAPAs, and periodic reviews.
• Ensure equipment is maintained in a validated state and methods are transferred per regulatory requirements.
• Author CMC submissions and other technical documents; support raw material qualification.
• Manage assay control and critical reagent qualifications; monitor method performance.
• Analyze QC data with statistics to identify trends and set limits.
• Provide scientific justification for investigations and recommendations.
• Meet deliverables and milestones; schedule AQC and QCM testing.
• Lead small teams; represent analytical projects with global and local sites for Right First Time.

Skills

Technical writing

Analytical methods

Method validation

Statistics

cGMP knowledge

Regulatory standards

Project management

Multi-tasking

Detail orientation

Microsoft Office

Education

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

Analytical development/validation experience (3+ years)

Tools

Laboratory instrumentation

Job description

USDM Life Sciences is seeking a QC Analytical Scientist II to support Analytical Quality Control (AQC) activities. You will transfer and execute analytical methods for CGMP environments, including QC microbiology, collaborating across teams to ensure quality and compliance.

The role emphasizes method development/validation, instrument qualification, investigations, and data analysis. A Bachelor’s degree is required with 3+ years in analytical development or validation in GMP settings, with