141 applicants

Company

Original Job Post

bluebird bio · 2 days ago

Senior Analyst II, Quality Control

United States

Full-time, Contract

Remote

Mid Level

4+ years exp

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BiotechnologyGenetics

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Responsibilities

Designing and overseeing QC laboratory studies for validation and remediation of QC methods.

Authoring and reviewing method lifecycle documents like protocols, reports, and SOPs.

Analyzing data using statistical software and/or Excel.

Owning and supporting cGMP routine testing and quality system records.

Participating in method monitoring of bioassay, molecular, and cell-based methods.

Tracking project status and communicating with cross-functional teams.

Qualification

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QC GMP environmentLate-stage clinicalCommercial experienceQualificationValidationQC test methodsCell-based assayPotency assayCell cultureQuality system recordsDeviationsLaboratory investigationsCAPAsOut-of-specification resultsStatistical software packagesJMPPrism

Required

Bachelor’s or Master’s degree in Biology, Biochemistry, or related scientific discipline.

A minimum of four (4) years of related experience in a QC GMP environment with late-stage clinical (Phase II, III) or commercial setting; commercial experience a plus.

Experience with development, qualification, and validation of QC test methods (i.e. cell-based assay, potency assay, and/or cell culture experience is desirable).

Experience with owning quality system records required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results

Good understanding of or proficiency with statistical software packages, such as JMP or Prism

Company

bluebird bio

Glassdoor

3.6

Bluebird Bio is a biopharma company that develops and commercializes gene therapies for the treatment of severe genetic diseases and cancer.

Founded in 1993

Somerville, Massachusetts, USA

201-500 employees

http://www.bluebirdbio.com

H1B Sponsorship

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2020 (42)