QA Compliance Specialist
QA Compliance Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Job Title: QA Compliance Specialist
Location: Onsite Indianapolis IN 46268 (Onsite)
Contract Duration: 6 Months (extendable)
Position type: C2C
Visa: Any
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
