On-Site Pharma QA Specialist I: Compliance & CAPA

BIOPHARMACEUTICAL RESEARCH COMPANY; Castroville (CA); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Vision insurance

Job summary

BIOPHARMACEUTICAL RESEARCH COMPANY seeks a QA Specialist to verify our quality program and ensure compliance with FDA, CDPH, and ICH standards. The role is on-site and full-time within a highly regulated manufacturing environment.

The ideal candidate will perform sampling, inspections, deviations investigations, and CAPA planning, while maintaining strict document control and adherence to company policies. Relocation or sponsorship are not offered.

Qualifications

• Experience in a highly regulated pharmaceutical manufacturing environment.
• Strong attention to detail and accuracy.
• Knowledge of GMP guidelines and FDA/CDPH/ICH standards.

Responsibilities

• Verify quality programs and ensure compliance with government regulations.
• Perform sampling and inspection of incoming, in-process and finished products.
• Review batch documentation and quality systems records for accuracy and compliance.
• Develop and implement CAPA plans in collaboration with production.
• Maintain documentation controls and write QMS documents when needed.
• Support training and assist with product quarantine, destruction, or rework as required.

Skills

Attention to detail

Regulatory compliance

Quality assurance

Tools

MasterControl

Job description

BIOPHARMACEUTICAL RESEARCH COMPANY seeks a QA Specialist to verify our quality program and ensure compliance with FDA, CDPH, and ICH standards. The role is on-site and full-time within a highly regulated manufacturing environment.

The ideal candidate will perform sampling, inspections, deviations investigations, and CAPA planning, while maintaining strict document control and adherence to company policies. Relocation or sponsorship are not offered.