QA Specialist

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Job description

The Quality Control Specialist I will be primarily responsible for oversight of environmental monitoring (EM) and critical utility (CU) trend reports, excursion investigations and facility and equipment qualification in support of our new GMP manufacturing at the Alnylam - Norton facility, 20 Commerce Way, Norton, MA and supporting the Alewife facility, 665 Concord Avenue, Cambridge, MA. The position requires flexibility with changing priorities.

Summary of Key Responsibilities

* Supporting the EM/CU program at the GMP manufacturing site at the Norton and Alewife facility.
* Perform trend analysis, troubleshooting, and support investigations (e.g. excursions and quality events) of the new cleanroom facility.
* Generate technical protocols and reports associated with facility and testing qualifications.
* Act in capacity as site Subject Matter Expert on microbiology related topics.
* Perform some QC testing (i.e., viable air, total particulate, TOC, conductivity, bioburden, endotoxin).
* Perform identification using MALDI-TOF.
* Ensures continuous GMP-compliant state of the laboratory and inspection readiness.
* Author and review technical documentation (e.g. SOPs, protocols, reports).
* Demonstrated technical ability in interpretation of compendia (USP, Ph. EUR, JP, etc.).
* Troubleshooting experience are required.

Qualifications

* Bachelor of Science in a scientific discipline (Microbiology, Biology, Biochemistry).
* 7 years of experience in a GMP laboratory.
* Experience with Bioburden and Endotoxin qualification.
* Experience performing Environmental Monitoring and Critical Utility testing.
* Experience performing Compressed Gas sampling.
* Experiencewiht compendia requirements (USP, Ph. EUR, and JP).
* Ability to travel between domestic sites (Norton, MA and Cambridge, MA).
* If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.