Quality Assurance Specialist

Translate Bio

Lexington, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 04/07/2021
  • Website: translate.bio
  • Company Address: 790 Memorial Drive Suite 203, Cambridge, MA, 02139

About Translate Bio

Translate Bio is focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases. The company’s RNA platforms for powering endogenous therapeutic protein production is applicable to a broad range of diseases caused by insufficient protein production, including rare diseases of the liver, lung and central nervous system (CNS).

Job Description

Company Overview

We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.

At Translate Bio, we’re also passionate about our five core values: Put People First, Be Approachable, Act as One, Be Tenacious, and Be Bold. These values embody our culture and underscore our mission to bring mRNA therapeutics to all.

Job Summary

The Quality Assurance Specialist reports to the Associate Director and is an integral part of the Quality team. This position offers opportunities to focus on disposition of product for Translate Bio, inclusive of review and release of manufacturing/test documentation from process development, manufacturing and nonclinical, clinical and commercial processes and supply chains.   This includes batch records, deviations, CAPAs, CoAs, CoCs, etc

Job Responsibilities

    Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
    Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
    Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
    Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
    Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
    Write and revise SOP, forms, WI, and any other document types
    Assist with internal and external audits.  
    Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.        
    Assume additional responsibilities as assigned.  

Required Skills & Qualifications

    Bachelor’s and/or 8+ years of relevant experience, Master’s preferred
    Minimum 4 years of experience in Quality Assurance
    Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
    Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
    Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
    Preferred experience with outsourced manufacturing and testing operations
    Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.