Manufacturing Data Specialist
TekWissen•Houston, TX
•Onsite
About The Position
The Manufacturing Data Compliance Specialist supports Manufacturing Science and Technology (MSAT) compliance activities for Viral Vector and/or Cell Therapy processes. The role helps ensure associated tasks, activities, and documentation are completed on time and in full. It includes verifying process data, using statistical software, tracking and trending data, managing material change controls, and supporting raw material documentation. The specialist maintains high-quality data collection systems and contributes to continuous improvement.
Requirements
- Knowledge of Manufacturing Science and Technology (MSAT) processes within Viral Vector and/or Cell Therapy manufacturing.
- Familiarity with Global Data Mart (GDM) and process data verification.
- Ability to work with STATISTICA statistical software.
- Understanding of process data tracking, trending, and data quality.
- Knowledge of Vendor Change Notifications (VCNs) and change control processes.
- Familiarity with material assessments, Part Number (PN) setup, and Raw Material List (RML) management.
- Strong documentation, analytical, organizational, and problem-solving skills.
- Ability to collaborate with cross-functional teams and manage assigned tasks within established timelines.
- Attention to detail and commitment to data accuracy and continuous improvement.
Responsibilities
- Verify process data entered into the Global Data Mart (GDM).
- Use STATISTICA statistical software to support process data activities.
- Support stakeholders with process data tracking and trending.
- Maintain high-quality data collection systems and contribute to continuous improvement initiatives.
- Assess Vendor Change Notifications (VCNs) for materials and manage associated change controls.
- Initiate material assessments and Part Number (PN) setup within agreed timelines under supervision.
- Support Raw Material List (RML) creation in collaboration with MSAT Scientists and cross-functional departments.
- Ensure accurate documentation and timely completion of assigned compliance activities.
- Proactively improve task efficiency and planning.
- Perform additional duties based on business needs.
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What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
