Lead Quality Assurance Specialist, Compliance

2 weeks ago


Manassas, Virginia, United States Granules Full time
Exciting Role: Lead Quality Assurance Specialist, Compliance

The position of Lead Quality Assurance Specialist, Compliance is pivotal in identifying and rectifying deficiencies in current good manufacturing practices (cGMP) for Granules Consumer Health. Collaborating closely with the QA Manager, Operations, Warehouse, and Supply Chain teams, this role is dedicated to ensuring adherence to compliance standards and executing corrective measures to align with FDA regulations. By actively engaging in site compliance enhancement, you will acquire practical experience in Pharmaceutical Packaging, with a strong emphasis on product safety and quality.

Key Responsibilities:

  • Evaluating cGMP Compliance deficiencies
  • Assisting in the implementation of Serialization and aggregation processes
  • Formulating strategies for gap resolution and ensuring ongoing cGMP Compliance
  • Reviewing Quality metrics data to improve quality and safety benchmarks
  • Participating in batch evaluations and equipment validation
  • Conducting investigations of cGMP deviations and root cause analysis
  • Spotting and communicating opportunities for continuous improvement
  • Contributing to the enhancement of skills in the application of FDA regulations
  • Advancing site compliance through effective corrective actions

Qualifications:

  • Bachelor's or Master's degree in Chemistry or a related discipline
  • At least 5 years of Quality Assurance experience within the Pharmaceutical Sector
  • Experience in Oral Solid Dosage (OSD) Pharmaceutical Packaging Operations
  • In-depth knowledge of cGMP
  • Expertise in cGMP protocols, Serialization, documentation, troubleshooting, and Microsoft applications
  • Strong communication abilities

Work Environment:

  • Laboratory setting with necessary safety equipment
  • 8-hour shifts requiring 6-8 hours of standing
  • Capability to lift up to 50 lbs


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