Job Description
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
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.
Numbers & Facts
| Location | Houston, TX |
| Industry | Computer/IT Services |
| Salary | $20–$24 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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