Senior Quality Control Specialist – Data-Driven Lab Quality

Planet Pharma; El Segundo (CA); On-site; USD 66,000 - 73,000; Full time

Job summary

Planet Pharma is seeking a Sr. Quality Control (QC) Specialist for our Santa Monica, CA location. You will support Product Quality, report to the Director of Analytical Method Lifecycle and Trending, and work cross-functionally with global QC SMEs and other Technical Operations teams.

Responsibilities include leading reporting and trending, data extraction from LIMs, and authoring key quality reports. Strong statistical skills (JMP/Minitab) and 21 CFR Part 11 knowledge are required.

Qualifications

• Masters degree with 4+ years in pharmaceutical/biotech quality
• Bachelors with 6+ years in quality function
• High School with 10+ years in quality function

Responsibilities

• Execute global reporting control and invalid trending programs.
• Extract data from LIMs system to support reporting requirements.
• Lead/coordinate continuous improvement activities with sites.
• Author Annual Product Review Laboratory Section.
• Author quarterly invalid and biannual control trending reports.
• Support new methods, technology, and KLIMS implementations.
• Meet reporting deadlines per procedure with strong prioritization.
• Communicate clearly with cross-functional teams.
• Improve processes to reduce complexity and optimize operations.
• Utilize JMP and/or Minitab for statistics and data analysis.
• Proficient with Microsoft Office applications.
• Understand and apply 21 CFR Part 11/210/211 quality system regulations.
• Maintain quality control, GMP, and GLP compliance.

Skills

Quality Control

Regulatory compliance

Data analysis

GMP/GLP knowledge

Education

Masters Degree

Bachelors Degree

High School Degree

Tools

JMP

Minitab

Job description

Planet Pharma is seeking a Sr. Quality Control (QC) Specialist for our Santa Monica, CA location. You will support Product Quality, report to the Director of Analytical Method Lifecycle and Trending, and work cross-functionally with global QC SMEs and other Technical Operations teams.

Responsibilities include leading reporting and trending, data extraction from LIMs, and authoring key quality reports. Strong statistical skills (JMP/Minitab) and 21 CFR Part 11 knowledge are required.