Data Management Associate
6701 Kaiser Dr Fremont, CA 94555
The Data Management Associate will be responsible for oversight of production sample management in support of New Product Introduction and technology transfer of both internal projects within BI and external projects from clients (Contract Manufacturing Business). The position will support creation of sampling plans for clinical and commercial GMP biopharmaceutical production as well as coordination of sampling execution during production and submission for Quality Control testing.
The position will perform data collection from GMP manufacturing and Quality Control documentation and testing results. The position will aggregate test results into spreadsheets, monitor test results, and compile data to generate reports to support the single-use multi-product GMP manufacturing facility (Flextrain).
These duties will be performed under limited supervision and according to standard operating procedures and work will be documented according to cGMP and cGDP and will adheres to established regulations established by the site.
Responsibilities include but are not limited to:
- Creation of sampling plans and associated documentation
- Coordination of sampling execution and delivery of samples to QC
- Creation of test request documentation
- Aggregation of test results into Excel
- Data collection from GMP manufacturing and Quality Control documentation
- Monitor, analyze and evaluate process data and trends
- Point of contact for sample management for clinical production runs
- Summarize data for campaign reports
- 0 – 3 years of experience in a related field. Very detail oriented with excellent organizational skills.
- Good written and oral communication skills. Ability to work in a cross-functional team environment. Eager to learn new skills and work in a fast-paced environment.
- Proficient with Microsoft Office, especially Word and Excel. Project management skills a plus.
- Bachelor' s Degree in a related field
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.