Manufacturing Data & Compliance Coordinator

DIRECT SALES, US; Marlboro (MA); On-site; USD 46,000 - 70,000; Full time

Job summary

Hologic is seeking a Manufacturing Data Coordinator to review Device History Records, reinforce GMP practices, and manage ERP data entry for material movements. The role supports production, performs backflush, cycle counts, and 5S audits to maintain high standards.

The ideal candidate has 3–5 years of quality inspection experience in medical manufacturing, with familiarity in Oracle and Agile, and strong attention to detail.

Qualifications

• Minimum of 3–5 years of related quality inspection experience in a medical manufacturing environment.
• Experience with Oracle and Agile preferred.
• Strong attention to detail and accuracy in documentation review and inspection processes.
• Ability to work independently with minimal supervision and make informed decisions.
• Excellent interpersonal and communication skills.
• Thorough understanding of GMP and GDP.
• Familiarity with QMS and regulatory requirements in medical device industry.

Responsibilities

• Perform detailed reviews of Device History Records (DHRs) for finished products, ensuring accuracy and compliance with documentation standards prior to final release.
• Communicate and reinforce GMP to manufacturing personnel to uphold quality standards.
• Generate folders and labels for manufacturing product lines as needed.
• Support production lines by assisting the process leader with material receipt and process control.
• Enter all material movement transactions into the ERP system, including receipt, transfers, consumption, outputs, sales, and labeling; ensure proper records management.

Skills

Attention to detail

Communication

Independent work

GMP knowledge

GDP knowledge

Education

High school diploma or technical school education

Tools

Oracle

Agile

Job description

Hologic is seeking a Manufacturing Data Coordinator to review Device History Records, reinforce GMP practices, and manage ERP data entry for material movements. The role supports production, performs backflush, cycle counts, and 5S audits to maintain high standards.

The ideal candidate has 3–5 years of quality inspection experience in medical manufacturing, with familiarity in Oracle and Agile, and strong attention to detail.