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The Steely Group http://www.thesteelygroup.com http://www.thesteelygroup.com true
QC Data Reviewer - 1st shift Monday to Friday
Norwood, MA 02062 US
Posted: 05/12/2023 2023-05-12 2023-07-07 Employment Type: Contract Job Category: Quality Job Number: 3486
In this role, you will support QC Labs with review of test records.
- Review executed QC test records for product release and environmental monitoring.
- Additional duties may be assigned
- BA or BS degree in Biology, Microbiology or similar field
- 5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.
- Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
- Previous experience managing quality records such as change controls, deviations, and lab investigations
- In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements
- Experience with rapid microbiological methods
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
- Wed-Sat Second Shift