Quality Control Analyst II - Labs & Compliance

Regulatory Jobs; Thousand Oaks (CA); On-site; USD 44,000 - 69,000; Full time

Job summary

Takeda in Thousand Oaks, CA is seeking a Quality Control Analyst II to manage analytical testing, perform analyses on raw materials, in-process and final products, and ensure data integrity throughout testing and documentation. You will collaborate with quality partners and leadership to maintain compliant laboratory operations.

You will review records, support investigations, and mentor less experienced analysts while adhering to FDA and GMP requirements.

Qualifications

• High school diploma or equivalent is required.
• At least three years of relevant laboratory or quality-control experience.
• Understanding of analytical methods, critical controls, expected assay behavior, and how sample handling can affect results.
• Ability to independently perform and assess routine and moderately complex laboratory analyses and recognize unusual patterns.

Responsibilities

• Manage assigned analytical testing from sample prep to handoff for review.
• Perform laboratory analyses of materials and products using approved methods and equipment.
• Assess controls, instruments, and results during testing to identify issues.
• Troubleshoot routine and moderately complex issues with methods and instruments; escalate when needed.
• Maintain and review testing records for accuracy, traceability, and compliance.
• Support investigations and improvements by reporting atypical results and preserving records.
• Coordinate readiness and coach analysts on methods and documentation.

Skills

Analytical testing

Laboratory analysis

Quality systems

Data review

Troubleshooting

Documentation

Mentoring

Collaboration

Education

High school diploma or equivalent

Tools

Microsoft Office

Laboratory data systems

Job description

Takeda in Thousand Oaks, CA is seeking a Quality Control Analyst II to manage analytical testing, perform analyses on raw materials, in-process and final products, and ensure data integrity throughout testing and documentation. You will collaborate with quality partners and leadership to maintain compliant laboratory operations.

You will review records, support investigations, and mentor less experienced analysts while adhering to FDA and GMP requirements.