<span>Quality Analyst</span>

$55,994 - $88,005/Yr

Takeda Pharmaceutical Company - Thousand Oaks, CA

Full-time - Entry Level

Thousand Oaks, CA

1,001-5,000 employees

Chemical Manufacturing

About the position

The Quality Analyst will oversee daily quality operations for Quality Lab Services within the Quality organization at Takeda. This role involves managing stability processes, conducting investigations, coordinating external lab testing, and ensuring compliance with quality standards. The analyst will also participate in quality process improvements and maintain critical quality data for product reviews.

Responsibilities

• Help manage the stability process for the Thousand Oaks Site.
• Conduct basic laboratory investigation activities, including LI initiation and investigation.
• Ensure roadblocks are identified and resolved, keeping LIs on track to meet target closure dates.
• Initiate deviations and support sample discrepancy report investigations.
• Identify areas of non-conformance and notify management per the deviation management process.
• Coordinate external lab testing for product release and safety testing.
• Process results from external labs to ensure minimal impact to product release.
• Prepare annual Product Quality Review (PQR) and Yearly Biologic Product Report (YBPR).
• Manage analytical instrument preventive maintenance process for QC labs.
• Assist with investigations for issues within respective area.
• Maintain departmental business indicators and prepare metrics for Management Review of Quality Systems.
• Support external and internal audits by maintaining audit records and creating reports.
• Identify and participate in process improvements within respective area.
• Write and review important documents such as Standard Operating Procedures (SOPs).
• Administer and maintain relevant databases, preparing and issuing reports as defined by the area.
• Participate in DMAIC and LEAN projects to meet continuous improvement objectives.

Requirements

• Bachelor's degree in chemistry or Biological Sciences.
• Minimum 1 year of related experience in quality operations or equivalent in a GMP manufacturing environment.
• Experience with SQL LIMS, Labware, MODA, JDE, and ARIBA.
• Documented/Certified training in DMAIC and LEAN concepts.
• Proficiency with MS Office suite (Word, Excel, PowerPoint).

Nice-to-haves

• Experience in a biotechnology or pharmaceutical environment.
• Knowledge of FDA Regulations and Good Laboratory Practices.
• Familiarity with quality systems including deviation management and change control.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Sick time and paid vacation accrual.