Overview
On Site
$DOE
Accepts corp to corp applications
Contract - W2
Contract - 6 Month(s)
Skills
Quality Management Review (QMR) Annual Product Quality Review (APQR) Self-inspections Audit readiness
Job Details
Job Title: QA Compliance Specialist
Contract Duration: 6+ Months (Renewable)
Location: Onsite Indianapolis, IN 46268 (Onsite)
Hours: 40 hours/week
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+)
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