Harba Solutions Inc. · 8 hours ago
Senior Quality Assurance Specialist
Indiana, United States
Full-time
Onsite
Senior Level
$85K/yr - $105K/yrHarba Solutions Inc. is seeking a Senior Quality Assurance Specialist to support site quality programs and GMP operations during second shift. This role involves ensuring compliance, mentoring junior QA staff, and driving continuous improvement in manufacturing activities.
OutsourcingRecruitingStaffing Agency
Hiring Manager
Alice Pozharskaia
Responsibilities
Review and approve GMP documentation including batch records, raw material records, deviations, validation documents, and change controls
Provide QA floor oversight to ensure compliance with procedures and regulatory expectations
Lead or support investigations involving process, equipment, or documentation issues, contributing to root cause analysis and CAPA
Perform material release activities (electronic/physical) for components, consumables, media, and incoming items
Support batch record review, product disposition, and reference sample program ownership
Collaborate with Engineering and Facilities on site support programs and quality-related initiatives
Mentor QA staff and provide rapid assessment of deviations, product impact, and containment needs
Utilize quality/manufacturing systems to ensure data integrity, traceability, and compliant documentation
Trend and analyze quality events to identify variability and drive continuous improvement in a fast-paced GMP environment
Qualification
Required
Extensive experience in pharmaceutical manufacturing environments (GMP)
Several years of direct Quality Assurance oversight within manufacturing operations
Demonstrated experience working with quality systems (QMS) and deviations, CAPA, documentation control, and change management
Strong understanding of regulatory expectations related to batch review and product disposition
Preferred
Bachelor's Degree in a scientific discipline preferred
Company
Harba Solutions Inc.
Harba Solutions is a U.S.-based services & workforce solutions company dedicated to connecting Life Sciences, Biotech, Pharmaceutical, Medtech, and Advanced Manufacturing Organizations with access to skills and talent that delivers delivers exceptional outcomes.
Founded in 2021
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ian Tyler
Group Chief Operating Officer
Recent News
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