QA Specialist II: CAPA & Deviation Oversight

Planet Pharma; El Segundo (CA); On-site; USD 48,000 - 58,000; Full time

Job summary

Planet Pharma in El Segundo, CA seeks a Quality Assurance Specialist II to execute QA activities ensuring compliance with quality objectives and regulatory requirements. The role includes oversight of deviations, OOS, CAPA, and change controls during manufacturing campaigns and support operations.

Typical workweek is M-F with weekend/night shifts during campaigns; requires strong documentation, collaboration, and the ability to adapt in a fast-paced biotech environment.

Qualifications

• Master's degree with relevant experience in biological sciences or related field
• Bachelor's Degree and 2+ years experience in the biological sciences or related field OR
• AA Degree and 4+ years experience in the biological sciences or related field OR
• High School Degree and 5+ years experience in the biological sciences or related field

Responsibilities

• Provide QA oversight and approval of deviation, OOS, and change control records with moderate to significant complexity
• Provide QA oversight and approval of CAPA and EV records with moderate to significant complexity
• Ensure escalation of deviations per procedures
• Identify efficiencies in the Deviation and CAPA processes at TCF03 in a compliant manner
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues
• Additional duties as assigned
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed

Skills

Quality Control

Analytical testing

Virological testing

Microbiological testing

Education

Master's Degree

Bachelor's Degree

AA Degree

High School Degree

Tools

MS Word

Excel

PowerPoint

Job description

Planet Pharma in El Segundo, CA seeks a Quality Assurance Specialist II to execute QA activities ensuring compliance with quality objectives and regulatory requirements. The role includes oversight of deviations, OOS, CAPA, and change controls during manufacturing campaigns and support operations.

Typical workweek is M-F with weekend/night shifts during campaigns; requires strong documentation, collaboration, and the ability to adapt in a fast-paced biotech environment.