Senior QA Specialist - Validation & Compliance

Planet Pharma; San Diego (CA); On-site; USD 95,000 - 124,000; Full time

Job summary

Planet Pharma seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation documents for solid oral dose and biologics programs. You will work with cross-functional teams to ensure compliance with regulatory requirements and QMS across vendor manufacturing and testing activities.

The role emphasizes reviewing technical documents, supporting stability reports, and maintaining knowledge of validation requirements.

Qualifications

• Bachelor’s degree in life science or related field; equivalent experience considered.
• 5+ years of GMP QA experience in biotech/pharma.
• Experience with qualification/validation of processes and methods; knowledge of QMS.

Responsibilities

• Assist qualification/validation documents for product transfers and regulatory compliance.
• Support review workflows and cross-functional teams using QMS.
• Participate in change controls, investigations, CAPA, and effectiveness checks.
• Review data and interim stability reports; ensure source data aligns with submissions.
• Travel up to 10% domestically and internationally; onsite in San Diego.

Skills

GMP QA experience

Quality documentation

Cross-functional collaboration

Regulatory compliance knowledge

Strong written/verbal communication

Education

Bachelor’s degree in life science or related field

Tools

Veeva QMS

Job description

Planet Pharma seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation documents for solid oral dose and biologics programs. You will work with cross-functional teams to ensure compliance with regulatory requirements and QMS across vendor manufacturing and testing activities.

The role emphasizes reviewing technical documents, supporting stability reports, and maintaining knowledge of validation requirements.