Specialist QA

QRC Group, LLC

Posted on : 14-06-2025

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1 Vacancy

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Jobs by Experience

4years

Job Location

Juncos - Puerto Rico

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 14-06-2025

Job Description

Specialist QA with expertise in Quality Systems such as Deviations (Non-conformities CAPA and Change Control). Hands on experience in electronic systems for instance: Documentation platforms (CDOCS) Maximo Trackwise LIMS electronic batch record (MES) and SAP. Experience with Validation of GxP applications Validation Master Plan Installation Qualification (IQ) Risk Assessment/GxP assessment Operational Qualification (OQ) and Performance Qualification (PQ) Protocols Test Scripts and Completion/Summary Reports approvals as per the compliance requirements. Validated experience as Quality Contact for sophisticated projects involving new drug substances /products with experience in commissioning and qualifications. Enhanced skills in leading influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.

Requirements

Doctorate or Masters Degree 2 years of directly related experience or
Bachelors Degree 4 years of directly related experience or
Associates 8 years of directly related experience
Computer Literacy
Bilingual (Spanish/English)

Employment Type

Full Time

Company Industry

Biotechnology Research / Pharmaceutical Manufacturing

Key Skills

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About Company

QRC Group, LLC

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Specialist QA

QRC Group, LLC

Job Description

Requirements

Employment Type

Company Industry

Key Skills

About Company

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