Backed by 500 Global.
About the role
Senior QA Analysts for FUJIFILM Diosynth Biotechnologies Texas LLC, College Station, TX. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- CGMP regulations for the production of drug, biologics or vaccine products
- Quality assurance in pharmaceutical or other regulated industry experience
- Deviation investigations and CAPA (Corrective Action/ Preventive Action)
- Performing real-time review and approval of production batch records
- Systems such as DeltaV , SAP, Veeva , TrackWise, and MasterControl platforms
More about this role
Senior QA Analysts for FUJIFILM Diosynth Biotechnologies Texas LLC, College Station, TX.
Responsible for review and/or approval of basic and technical documentation, drafting and reviewing internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally for drug, biologics or vaccine products. Provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager. Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to: Standard Operating Procedures; Batch Production Records (completed and approval); Commissioning, qualification and validation protocols and reports; Deviation Reports; Corrective Action/Preventive Action Plans; Technical data review and approval; QC data review and approval; Drug Substance/Product Reports; and Trending QA data. Draft and review internal Quality policies, procedures, and reports. Perform inspection of...
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