Quality Control Analyst I

Responsibilities

• Execute routine in-process, drug substance, and stability test methods using various laboratory instrumentation and computer systems.
• Maintain laboratory operations, including cleaning, ordering supplies, reagent preparation, and waste disposal.
• Ensure data integrity and compliance with company SOPs, specifications, and cGMP regulations.
• Conduct facility monitoring, including Environmental Monitoring and Critical Utility Monitoring.
• Support low-risk deviations, CAPAs, and change controls within the electronic Quality Management System.
• Perform equipment maintenance and calibrations as required.
• Author minor revisions to existing Standard Operating Procedures (SOPs).

Requirements

• Bachelor's or Master's degree in Life Sciences with relevant laboratory coursework.
• 0-3 years of relevant laboratory experience.
• Proficiency in analytical techniques such as HPLC, UPLC, or UV-Vis.
• Experience with bioassays including ELISA, cell maintenance, or cell-based assays.
• Strong micropipetting skills and aseptic technique.
• Basic computer skills, including proficiency with word processing, spreadsheets, and databases.
• Ability to communicate effectively in English and work collaboratively in a team environment.

Preferred Qualifications

• Previous experience working in a regulated cGMP manufacturing environment.
• Familiarity with laboratory software such as LIMS, Empower, or SoftmaxPro.
• Knowledge of chemical, biological, and/or microbiological safety procedures.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance and tuition reimbursement programs.
• Paid vacation and sick time.
• Paid volunteer time off and well-being benefits.

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.