Senior Quality Control Analyst

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Control Analyst Specialist at our Thousand Oaks, CA site. Here, you will be a vital contributor to our inspiring, bold mission.

Summary:

The QC Analyst is responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, final product samples and other samples collected from manufacturing areas.

Title: Quality Control Analyst

Department: QC Microbiology

Location: Thousand Oaks, CA - Onsite

Pay: $45-$55/hr.

Duration: 6 months w/ potential for extension

Additional Responsibilities:

• Apply advanced laboratory skills to perform complex assays requiring precise analytical skills and understanding of microbiology and chemistry principles.
• Wet Chemistry, knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals. This can include tasks such as preparing chemical solutions, conducting chemical reactions, and analyzing chemical compounds using various wet chemical techniques such as titrations, extractions, filtrations, and precipitation.
• Raw Materials, Product Release, and Stability Monitoring Testing (Routing and on-demand)
• Ordering, Troubleshooting, Service Catalog Ordering, Schedule Repairs and Preventive Maintenance of HPLC/Raw Material Instruments
• Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in LIMS or other computerized systems.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and CGMP regulations.
• Investigate complex nonconformances and write exception documents or lead others in writing investigation.
• Column/Control/Standard Qualification for release testing

Qualifications:

• Bachelor’s Degree in Chemistry, Microbiology or Biological Sciences strongly preferred. With 3 years' industry experience
• Experienced in Wet Chemistry - deep understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices
• Familiar with the USP, EP, and JP Pharmacopeia and troubleshoot issues that arise during experimentation
• HPLC Testing, Raw Material, Elisa (preferred), LIMs
• Endotoxin Testing, Bioburden testing, and/or TOC/Conductivity testing
• Knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices
• Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus