What are the responsibilities and job description for the Quality Assurance Specialist position at United Pharma?
Now Hiring: Quality Assurance Specialist
Location: California
We are seeking an experienced Quality Assurance Specialist to support quality systems, compliance activities, and GMP operations within a pharmaceutical, biotech, or medical device environment.
The ideal candidate will have experience with quality documentation, deviations, CAPAs, change controls, audits, batch record review, and regulatory compliance. This role will work closely with Manufacturing, Quality Control, Validation, and Regulatory teams to ensure products and processes meet company and FDA quality standards.
Key Responsibilities:
• Support quality assurance and compliance activities in a GMP-regulated environment
• Review batch records, SOPs, deviations, CAPAs, and change controls
• Assist with internal audits, investigations, and quality documentation
• Ensure compliance with FDA, GMP, and company quality standards
• Collaborate with cross-functional teams to support manufacturing and quality operations
• Support continuous improvement and quality system initiatives
Requirements:
• Experience in pharmaceutical, biotech, medical device, or life sciences industries
• Knowledge of GMP, FDA regulations, and quality systems
• Strong documentation review and problem-solving skills
• Experience with deviations, CAPAs, audits, and compliance activities
• Excellent communication and organizational skills