Apply on Employer Site

ELITechGroup - A Bruker Company · 3 weeks ago

Quality Assurance Associate at Biotech Company

Bothell,WA,US

Full-time

Onsite

Entry Level

$30/hr - $32/hr

2+ years exp

ELITechGroup is a successful biotech company committed to supporting health systems globally. They are seeking an experienced and detail-oriented Associate to join their Quality Assurance team, focusing on ensuring compliance with regulatory and industry expectations in the manufacturing of in vitro diagnostic products.

BiotechnologyHealth CareInformation TechnologyLogisticsManufacturingMedical

No H1B

Responsibilities

Performs review of manufacturing batch records, enter information in Disposition Log, filing of batch records, and ensure the records are complete and stored in a manner where they are readily retrievable

Performs finished product inspection

Performs review and approval of labels

Reviews SPEC sheets, enter information in Disposition Log, file

Assists QA with the tracking and/or completion of CAPAs and Customer Complaints

Assists QA with the tracking and/or completion of NCRs, OOSs, TMPs

Assigns part numbers

Reviews, tracks, and files training forms. Ensures the training log is updated

Reviews calibration/maintenance records, update tracking log, file

Ensure the records are complete and stored in a manner where they are readily retrievable

Participates during audits (FDA, ISO, vendor)

Assists Document Control, (assign CC and document numbers, assist in obtaining approvals, auditing external documents, etc.) when necessary

Other duties and task as assigned