Quality Assurance Specialist

Rose International; Oceanside (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Rose International in Oceanside, California seeks a Quality Assurance Specialist II to ensure compliance with quality objectives and regulatory requirements in a fast-paced biopharma setting. You will perform batch record reviews, line clearance, and provide on-the-floor QA support to enable timely product release.

The role requires hands-on GMP experience, familiarity with deviations, CAPAs, change controls, and regulatory inspections, plus knowledge of US/EU GMP standards.

Qualifications

• Hands-on QA background in GMP manufacturing.
• Master’s degree or Bachelor’s with biology/science experience, or AA with years of relevant work.
• Experience with GMP regulatory requirements and quality systems.

Responsibilities

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

Skills

Analytical QC

Strong communication

Teamwork

Education

Master’s degree in biological sciences

Bachelor’s degree + 2+ years in biological sciences

AA degree + 4+ years in biological sciences

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!