Title: QC Microbiologist
Location: College Station, TX
Duration : Fulltime Permanent / Contract both open
- Experience with MODA-EM and LIMS system including system management, understanding test configurations and user requirements.
- Experience with developing trending programs, EMPQs, testing protocols and test methods.
- In depth understanding aseptic processing and sterile manufacturing operations.
- Experience with biological indicators and qualification protocols.
- Experience with leading continuous improvement projects and quality improvement plans.
- Experience with microbial testing, aseptic processing, microbial data deviation investigations and CAPAs.
- Experience with Track Wise, Master Control and Quality Management Systems.
- Experience with conducting reviews for APS (Aseptic process simulations) programs.
- Experience with biologics manufacturing.
- Good understanding of the regulatory guidance documents such as FDA, EU and JP.
- Experience with Bioburden testing, endotoxin testing, environmental monitoring and Utilities monitoring (Compressed air, gases and water).
- Experience with analyzing environmental monitoring data, establishing alert and action limits.
- Perform risk assessments and write technical reports.
Thanks
Ritika Aithmian
Lead Recruiter
D : +1 617-848-2313 (P)| +1 984-262-2736
Ritika.aithmian@mastechdigital.com