Quality Operations Analyst II – GMP Floor Support

Takeda Pharmaceutical Company Limited; Adams (MA); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda Pharmaceutical Company Limited is seeking a Quality Operations Analyst II, Floor Support in Massachusetts to provide routine quality oversight of GMP operations and real-time compliance support. You will review documents, assist with deviations and CAPAs, and collaborate with Manufacturing, Facilities, Engineering, QA, and Regulatory Affairs to ensure product quality and patient safety.

The role emphasizes adherence to GMP/GDP, data integrity, and continuous improvement, with a focus on

Qualifications

• Bachelor's degree or higher with relevant life sciences experience.
• Experience in QA, manufacturing, QC, validation or GMP-regulated field.
• Knowledge of GMP, GDP, data integrity and quality systems.
• Familiarity with documentation review and issue resolution.

Responsibilities

• Provide routine quality oversight and real-time support of GMP operations.
• Perform area walkthroughs and compliance assessments per SOPs and regulations.
• Review, issue, and approve batch records, logbooks, and quality documents.
• Support cross-functional teams in resolving quality/compliance concerns.
• Monitor quality metrics and support continuous improvement.
• Support deviations, CAPAs, change controls, audits, and regulatory inspections.

Skills

Interpersonal skills

Attention to detail

Problem solving

Verbal and written communication

Independent work

Education

Bachelor's degree or higher in life sciences or related field

Tools

TrackWise

SAP

LIMS

EDMS

Veeva

Job description

Takeda Pharmaceutical Company Limited is seeking a Quality Operations Analyst II, Floor Support in Massachusetts to provide routine quality oversight of GMP operations and real-time compliance support. You will review documents, assist with deviations and CAPAs, and collaborate with Manufacturing, Facilities, Engineering, QA, and Regulatory Affairs to ensure product quality and patient safety.

The role emphasizes adherence to GMP/GDP, data integrity, and continuous improvement, with a focus on