Quality Control Analyst II

Responsibilities

• Perform compendial assessments to ensure compliance with regulatory requirements and pharmacopeial standards
• Author and review technical documents, including protocols, SOPs, and analytical methodologies
• Design and coordinate analytical method onboarding activities, including execution planning and training
• Lead the qualification of critical materials and oversee change control management processes
• Manage Corrective and Preventive Actions (CAPAs) and support the timely closure of quality events
• Act as a Subject Matter Expert (SME) to provide technical guidance and troubleshooting for laboratory teams
• Conduct routine data trending and analysis of laboratory processes to identify areas for improvement
• Collaborate with global and local teams on cross-functional quality initiatives

Requirements

• Bachelor's degree in science, engineering, or a related technical field
• 2-5 years of experience in the pharmaceutical or a similar regulated industry
• Strong knowledge of quality laboratory operations and government regulations (pharmaceutical/medical device)
• Ability to manage multiple tasks, complex projects, and resolve laboratory issues
• Excellent technical and interpersonal communication skills

Preferred Qualifications

• Advanced knowledge of Statistical Analysis
• Strong understanding of cGMP standards
• Proven leadership, project management, and decision-making skills

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 and company holidays
• Paid vacation and sick time

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything they do. Driven by the values of Integrity, Fairness, Honesty, and Perseverance, Takeda strives to deliver better health and a brighter future through leading innovation in medicine.