Role OverviewThis position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. Primary responsibilities will be performing QC analysis in compliance to cGMP in line with standards prescribed by USFDA.
What You Will Do
Perform QC analysis, maintain compliance to data integrity and cGMP, execute and complete procedures and systems for RM, PM, FD and in process testing, provide information and data for evaluation and execution of stability study, and ensure compliance during analytical TT and AMV.
Why It Might Be a Fit
The ideal candidate will have a B.Sc. in Chemistry with concentration in Biochemistry, 1-3 years of experience in the field of Pharmaceutical manufacturing, and extensive knowledge in general laboratory equipment.
Requirements
- B.Sc. in Chemistry with concentration in Biochemistry
- 1-3 years of experience in Pharmaceutical manufacturing
- Extensive knowledge in general laboratory equipment
- Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market compliant management system
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