Biopharma QA Specialist II: Drive GMP Compliance & Quality

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.

Skills

QA-related production activities

GMP compliance

Analytical skills

Interpersonal communication

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

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.