QA Specialist

Integrated Resources, IncCambridge, MA

Apply with Sonara

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.¹

Reclaim your time by letting our AI handle the grunt work of job searching.

We continuously scan millions of openings to find your top matches.

Overview

Remote

On-site

Job Description

QA SpecialistPerform the QA review/approval of analytical documentation: Analytical method validation protocols and reports for in-process and release/stability testing Analytical method procedures and associated change controls Method technical transfer protocols and reports Reference Standard and Critical Reagent qualification protocols and reports Certificates of Analysis for reference materials and critical reagents Standard Operating Procedures and other guidance documents Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications Collaborate with manufacturing support functions to develop the methods and acceptance criteria for the development of raw material specifications in preparation for Process Performance Qualification activities Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials Experience with the review and approval of method validation protocols and reports Experience collaborating with technical teams to develop validation strategies that are compliant to regulatory guidance and BMS policies Experience collaborating with technical subject matter experts to resolve validation protocol or report compliance gaps and indicate if technical gaps are present with the overall validation strategy Experience collaborating with technical subject matter experts to resolve protocol deviations and investigations

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.

Apply with Sonara Apply manually

FAQs About QA Specialist Jobs at Integrated Resources, Inc

What is the work location for this position at Integrated Resources, Inc?

This job at Integrated Resources, Inc is located in Cambridge, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Integrated Resources, Inc?

Employer has not shared pay details for this role.

What employment applies to this position at Integrated Resources, Inc?

The employer has not provided this information. This may be discussed during the hiring process.

What is the process to apply for this position at Integrated Resources, Inc?

You can apply for this role at Integrated Resources, Inc either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.