Sarepta Therapeutics · 3 days ago

Associate II, Quality Control

Andover, MA

Full-time

Onsite

Entry, Mid Level

$72K/yr - $90K/yr

2+ years exp

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BiotechnologyGenetics

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Responsibilities

Perform routine and non-routine analytical tests of custom raw material per cGMP for release and stability samples using HPLC, GC, KF, and other general laboratory techniques.

Review raw data, protocols, reports, and CoA/CoTs for release and stability of RNA based products and AAV based gene therapy products generated internally and at vendor sites.

Create and maintain clear and concise lab records and documentation.

Monitor, review, and trend stability data.

Assist in writing and reviewing quality documents such as test methods, SOP, change controls, and investigations originated internally and at vendor sites.

Support method transfer and qualification/validation activities associated with the release of raw materials for RNA and AAV platforms.

Perform other related duties incidental to the work described.

Qualification

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General Laboratory OrganizationExperimental DesignDocumentation (GDP)CGMP AdherenceAuthorization to Work in the U.S.Attention to DetailsOrganizational SkillsEffective CommunicationTeamworkHPLCGCKFPHQPCRELISASDS-PAGESanger sequencingUV spectrophotometry