Quality Control Analyst II

About the position

Takeda Manufacturing U.S.A., Inc. is seeking a Quality Control Analyst II with the following duties: Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers; conduct critical biological test methods (Endotoxin, Bioburden, Environmental Monitoring, pharmaceutical water systems, aseptic technique) including samples generated for in-process, drug substance and stability; use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS); initiate and own deviations, CAPAs and change controls within the electronic Quality Management System; exercise judgment within generally defined Quality Control procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions; provide training to new QC Analysts on routine procedures and practices; complete all testing, including special project/protocol testing; maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations; draft studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors; author new SOPs and initiates changes to existing procedures.

Responsibilities

• Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers.
• Conduct critical biological test methods including Endotoxin, Bioburden, Environmental Monitoring, pharmaceutical water systems, and aseptic technique.
• Use a variety of laboratory instrumentation and computer systems to collect and record data.
• Initiate and own deviations, CAPAs and change controls within the electronic Quality Management System.
• Exercise judgment within generally defined Quality Control procedures and practices.
• Provide training to new QC Analysts on routine procedures and practices.
• Complete all testing, including special project/protocol testing.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Draft studies and investigations of moderate scope.
• Author new SOPs and initiate changes to existing procedures.

Requirements

• Bachelor’s degree in Biology, Environmental Science, Biochemistry or related field or foreign academic equivalent.
• 5 years of related experience.
• Perform microbiological and/or physical tests on raw material, in-process products and finished products.
• Initiate low severity level deviations and laboratory investigations within the electronic Quality Management System.
• Conduct critical biological test methods including samples generated for in-process and drug substance.
• Use a variety of laboratory instrumentation and computer systems to collect and record data.

Benefits

• Medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• Up to 120 hours of paid vacation for new hires.