QA Batch Record Reviewers
QA Batch Record Reviewers (QA Specialist)
Strong understanding of quality systems and compliance requirements
Have demonstrated exp. In working with batch records and associated process/systems
biologics exp with understanding of unit operations – cell culture, bioreactor, TFF, Chromatography, filtrations, etc. is highly desired
Familiarity of Single use disposable systems • Preferred exp. in mfg and/or quality setting
Detail oriented with strong understanding of data integrity, GDP, and cGMP requirements
Have worked with batch records and have familiarity with workings of cGMP mfg environment
Life science or engineering degree with atleast 1+ yrs of direct relevant exp.
Use of TrackWise and ERP system is highly desired
Job Type: Full-time
Pay: $30.00 - $40.00 per hour
Expected hours: 40 per week
Schedule:
8 hour shift
Work Location: In person