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Norwood, MA 02062

Posted: 05/12/2023 Employment Type: Contract Job Category: Quality Job Number: 3486

Job Description

In this role, you will support QC Labs with review of test records.

Responsibilities:

Review executed QC test records for product release and environmental monitoring.
Additional duties may be assigned

Requirements / Qualifications:

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

Preferred Qualifications:

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

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