QA Compliance Specialist Job at Accord Technologies Inc., Indianapolis, IN

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  • Accord Technologies Inc.
  • Indianapolis, IN

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+)

Job Tags

Full time, Contract work, Part time, Seasonal work,

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