QA Compliance Specialist

Marvel Infotech

Posted on : 14-07-2025

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1 Vacancy

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Job Location

Indianapolis, IN - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 14-07-2025

Job Description

Job Title: QA Compliance Specialist

Location: Indianapolis IN (Onsite)

Contract Duration: 6 Months (Extension)

Must have: GMP-regulated biopharmaceutical environment QMR APQR FDA/ICH/EU cGMP

Description:

GMP Experience

Minimum 8 years in a GMP-regulated biopharmaceutical environment

Quality Assurance Experience

At least 2 years specifically in a QA role

QA Compliance Knowledge

Strong knowledge of QA Compliance systems including:
- Quality Management Review (QMR)
- Annual Product Quality Review (APQR)
- Self-inspections
- Audit readiness

Regulatory Knowledge

In-depth understanding of FDA/ICH/EU cGMP regulations and guidelines

Data Integrity

Experience with Data Integrity principles (ALCOA)

Employment Type

Full-time

Company Industry

Key Skills

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About Company

Marvel Infotech

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