Manufacturing Data Specialist

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Job Title: Manufacturing Data Compliance Specialist



Location: Houston TX 77047



Duration: 6 Months



Job Type: Temporary Assignment



Work Type: Onsite

Summary:

The MSAT Data & Compliance Coordinator / Manufacturing Data Compliance Specialist is responsible for supporting Manufacturing Science and Technology (MSAT) compliance activities for Viral Vector and/or Cell Therapy processes to ensure on-time and in-full delivery of associated tasks, activities, and documentation. The role involves process data verification, statistical software utilization, data tracking and trending, material change control, and supporting raw material documentation while maintaining high-quality data collection systems and driving continuous improvement.

Responsibilities:

• Verify process data entered into the Global Data Mart (GDM).
• Utilize 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.

Required Skills

• 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.