What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Harba Solutions Inc.?
Key Responsibilities
- Review and approve quality documentation, including batch records, deviations, change controls, and validation-related documents
- Partner with Manufacturing and Operations to support and/or lead deviation investigations, including root cause analysis and corrective actions
- Maintain a strong QA presence on the manufacturing floor to ensure compliance and provide real-time support
- Balance production timelines with quality requirements to support efficient operations
- Perform material review and release activities for raw materials, components, and consumables
- Support batch record review, product disposition, and overall release processes
- Mentor and provide guidance to QA team members on shift
- Make real-time quality decisions regarding deviations, product impact, and escalation needs
- Contribute to deviation investigations, CAPA development, and risk assessments
- Ensure adherence to SOPs, regulatory requirements, and site quality standards
- Utilize electronic and paper-based systems (QMS, LIMS, etc.) to maintain data integrity
- Analyze quality trends and identify sources of variability using data and statistical tools
- Manage multiple priorities in a fast-paced GMP environment
Qualifications
- Bachelor’s degree in a scientific discipline (or equivalent experience)
- 8 years of experience in a GMP-regulated manufacturing environment
- 4 years of direct QA oversight supporting manufacturing operations
- Experience with quality systems, including deviations, CAPA, and change control
- Strong understanding of GMP regulations and product disposition processes
- Excellent written and verbal communication skills
- Experience with data analysis tools and manufacturing systems is preferred
Salary : $80,000 - $100,000