Job Description:

• The Analyst II, Quality Control will help in the implementation of laboratory equipment and enterprise/local software systems at Alnylam’s GMP laboratories in Norton, MA supporting drug substance manufacturing. 

• This position will be heavily focused on Laboratory Equipment Qualification, Implementation of a LabWare LIMS system, and validation of QC computerized systems.

• Demonstrated technical writing and validation knowledge is required. This position requires flexibility with changing priorities and may require occasional travel to company sites in Cambridge, MA.

• The role will be based in Norton, MA. 

Skills"

• Minimum of 2 – 4 years of experience in a GMP laboratory or software validation setting.

• Experience with QC analytical instrumentation and software systems (UPLC / UPLC-MS, Karl Fischer, FTIR, TOC, spectroscopy, etc.).

• Knowledge of analytical equipment qualification per USP <1058>, and software validation in compliance with 21 CFR Part 11 and EU Annex 11 are desired.

• Experience with LabWare LIMS and design/implementation is ideal.

Education:

• B.S. in applicable science field

Required

• Software validation

• Analytical instrumentation

• Laboratory equipment

• Labware

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.