Data Entry Specialist - GDM & cGMP Compliance

Katalyst CRO; Portsmouth (NH); On-site; USD 42,000 - 64,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH seeks a Data Entry Specialist to locate, collect, transcribe, and verify batch record data for the Global Data Mart (GDM). You will support MSAT, Process Analytics, Process Validation, and Investigation teams with accurate, timely data for manufacturing operations.

The role requires high attention to detail, understanding of process flows, and adherence to cGMP standards to maintain data integrity for daily monitoring and analytics.

Qualifications

• High School Diploma or equivalent.
• 3 years of experience in biotech, pharmaceutical, or related industries preferred.
• Strong computer skills, including proficiency in Microsoft Office.
• Highly detail-oriented, self-motivated, and able to work independently.
• Strong commitment to accuracy, data integrity, and compliance.

Responsibilities

• Enter and verify batch record data with high accuracy.
• Manage and track workload to ensure data is located and entered.
• Use tools and tracking methods for daily data entry tasks.
• Provide timely and accurate data for daily process monitoring.
• Handle special requests for data collection and verification.
• Ensure data entry procedures and guidelines are current and followed.
• Maintain 100% accuracy and right-first-time data entries.

Skills

Detail oriented

Microsoft Office

Independent work

Data integrity

Education

High School Diploma

Tools

Statistica Enterprise Architecture

ComplianceWire

SAP Learning Portal

Job description

Katalyst CRO in Portsmouth, NH seeks a Data Entry Specialist to locate, collect, transcribe, and verify batch record data for the Global Data Mart (GDM). You will support MSAT, Process Analytics, Process Validation, and Investigation teams with accurate, timely data for manufacturing operations.

The role requires high attention to detail, understanding of process flows, and adherence to cGMP standards to maintain data integrity for daily monitoring and analytics.