GMP Quality Operations Analyst II — Floor Support

Takeda Pharmaceutical Co.; Cambridge (MA); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda Pharmaceutical Co. in Massachusetts is seeking a Quality Operations, Analyst II, Floor Support to provide quality oversight in a biotechnology manufacturing environment.

You will collaborate with Manufacturing, Facilities, Engineering, and Regulatory Affairs to maintain inspection readiness and support release of high-quality products. Responsibilites include performing area walkthroughs, reviewing documents, and assisting cross-functional teams in resolving quality and compliance

Qualifications

• Bachelor’s degree or higher with 4+ years of relevant industry experience in life sciences, engineering, chemistry, microbiology, biotechnology, or a related field preferred.
• At least 3 years of experience in Quality Assurance, manufacturing, Quality Control, validation, or a related GMP-regulated field.
• Knowledge of GMP, GDP, data integrity, quality systems, and quality risk management.
• Experience with document review and issue resolution.

Responsibilities

• Provide routine quality oversight and real-time support of GMP manufacturing operations.
• Perform area walkthroughs and compliance assessments to ensure adherence to GMP, SOPs, and regulatory expectations.
• Review and approve documents such as batch records, logbooks, protocols, and reports.

Skills

Quality Assurance

GMP

Documentation

Problem solving

Teamwork

Communication

Attention to detail

Education

Bachelor's degree in life sciences or related

Tools

TrackWise

SAP

LIMS

EDMS

Veeva

Job description

Takeda Pharmaceutical Co. in Massachusetts is seeking a Quality Operations, Analyst II, Floor Support to provide quality oversight in a biotechnology manufacturing environment.

You will collaborate with Manufacturing, Facilities, Engineering, and Regulatory Affairs to maintain inspection readiness and support release of high-quality products. Responsibilites include performing area walkthroughs, reviewing documents, and assisting cross-functional teams in resolving quality and compliance