Quality Assurance Specialist

Rose International; Oceanside (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

A biopharma company in California is seeking a highly motivated Quality Assurance Specialist II to ensure compliance with quality objectives in a fast-paced environment. The role involves performing QA-related production activities, providing oversight for QC tasks, ensuring GMP compliance, and supporting regulatory inspections. Candidates should have a strong background in analytical QC and knowledge of U.S. and EU GMP standards. This position offers an exciting opportunity to work in a collaborative high-compliance setting.

Qualifications

• Hands-on QA background in GMP manufacturing environment.
• Experience in analytical, virological, or microbiological QC.
• Strong knowledge of U.S. and EU GMP standards.

Responsibilities

• Perform QA-related production activities including batch record review.
• Provide QA oversight for QC activities like method transfer.
• Ensure timely closure of deviations and CAPAs.
• Ensure timely closure of deviations, CAPAs, change controls, and investigations.
• Conduct walk-throughs and process observations to ensure GMP compliance.
• Support regulatory inspections and maintain document control/training records.
• Escalate compliance risks and issues affecting product release.
• Generate and update procedures and forms as needed.

Skills

QA-related production activities

GMP compliance

Analytical skills

Interpersonal communication

Regulatory compliance

Education

Master’s Degree

Bachelor’s Degree + 2+ years of experience

AA Degree + 4+ years’ experience

High School Diploma + 5+ years’ experience

Tools

Veeva

Smartsheet

LIMS

Job description

We are seeking a highly motivated Quality Assurance Specialist II to join our team and help ensure compliance with quality objectives and regulatory requirements in a fast-paced biopharma environment.

Key Responsibilities

• Perform QA-related production activities, including batch record review, line clearance, and on-the-floor support
• Provide QA oversight for QC activities (method transfer, Certificate of Analysis, stability)
• Approve shipments and oversee product packaging
• Ensure timely closure of deviations, CAPAs, change controls, laboratory investigations, and batch/material holds
• Conduct walk-throughs and process observations to ensure GMP compliance
• Support regulatory inspections and maintain document control/training records
• Escalate compliance risks and issues affecting product release
• Generate and update procedures and forms as needed

Preferred Qualifications

• Background in analytical, virological, or microbiological QC
• Strong knowledge of U.S. and EU GMP standards
• Experience with Veeva, Smartsheet, and LIMS preferred
• Excellent interpersonal, verbal, and written communication skills
• Comfortable working in a fast-paced, dynamic environment

Education Requirements

• Master’s Degree OR
• Bachelor’s Degree + 2+ years of experience in biological sciences OR
• AA Degree + 4+ years’ experience OR
• High School Diploma + 5+ years’ experience

If you have a hands-on QA background in a GMP manufacturing environment and thrive in a collaborative, high-compliance setting, we’d love to hear from you!