QA Documentation Specialist-I

Job Title: QA Documentation Specialist-I

Duration: 6 Months

Location: Foster City, 94404

Responsibilities:

• Specializing in compliance and regulatory affairs in the pharmaceuticals & biologics sectors.
• Meticulous Quality Assurance Auditor with over 5 years of experience leading QA/QC programs to drive strict compliance with diverse regulatory requirements, including FDA, USDA, International Standards, safety regulations, and industry-specific governance.
• Drive compliance with multiple regulatory requirements, International Standards, and company policies and procedures by auditing records and reports, inspecting processes and documents, reviewing SOPs, and independently monitoring all facilities, operations, personnel, and materials.
• Adept at managing and mitigating risk, using a proactive approach to identify issues and collaborate with leaders to create and implement corrective action.
• Skilled in root cause analysis, multi-phase product sampling and testing, and ensure compliance of equipment and facility inspections.
• Carefully document testing and audit results in Quality Assurance Logs and process records, and shared test results with production workers, supervisors and managers to identify and implement solutions.
• Extensive experience in process, internal audit, and documentation approval to ensure the availability and security of historical data and records.
• Utilized Trackwise as Electronic Document management system.

3+ years of relevant experience in a regulated industry and an AS degree. 

EDMS experience is must

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

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