Job Description: The Data Entry Specialist is responsible for locating, collecting, transcribing, and verifying batch record data into the Global Data Mart (GDM). This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations. The position requires strong attention to detail, understanding of process flows, and adherence to cGMP standards to maintain data integrity and support daily process monitoring and analytics.
Responsibilities: Data Entry & Verification (80%): - Enter and verify large volumes of batch record data with high accuracy and consistency.
- Manage and track workload to ensure all required process data is located, collected, and entered.
- Use existing tools and develop simple tracking methods to manage daily data entry tasks.
- Provide timely and accurate data entry to support daily process monitoring and related activities.
- Handle special requests for data collection, completion, and verification.
- Ensure all data entry procedures and guidelines are current and followed.
- Maintain 100% accuracy and "rightfirsttime" standards for all data entered.
Process & Analytics Understanding (5%):
- Develop a basic understanding of how data collection supports process monitoring and analytics.
- Learn key manufacturing process technologies, terminology, and analysis tools.
- Gain familiarity with Statistica Enterprise Architecture to support data collection system maintenance.
User Interaction & Support (5%):
- Interact routinely with data consumers to support efficient data usage.
- Help build user confidence in GDM by ensuring data accuracy and responsiveness.
- Observe how users interact with GDM and provide support based on their needs.
- Troubleshoot and resolve dataentryrelated analytics issues.
Training & Compliance (10%):
- Follow all training, policy, and cGMP requirements for the facility.
- Maintain an uptodate training profile by completing assigned training in systems such as ComplianceWire and SAP Learning Portal.
- Ensure continuous compliance with data integrity and documentation standards.
Additional Responsibilities:
- Perform other duties as assigned by management.
Education Requirements:
- High School Diploma or equivalent (required).
- 0-3 years of experience in biotech, pharmaceutical, or related industries preferred.
- Exposure to data collection systems or manufacturing data environments is an advantage.
- Strong computer skills, including proficiency in Microsoft Office.
- Highly detailoriented, selfmotivated, and able to work independently.
- Strong commitment to accuracy, data integrity, and compliance.
