Senior QC Specialist – Hybrid (Pharma/Biotech)

Planet Group; Santa Monica (CA); On-site; USD 69,000 - 74,000; Full time

Job summary

Planet Group is seeking a Sr. Quality Control (QC) Specialist for an onsite role in California. The position is a 5-month contract with an initial on-site period in Santa Monica, some remote time, and a return to Thousand Oaks.

Responsibilities include data extraction from LIMs, execution of reporting programs, and coordination of continuous improvement with site teams. Proficiency in JMP/Minitab and strong regulatory knowledge (21 CFR Part 11/210/211) are required.

Qualifications

• Master's or Bachelor's degree with 4+ or 6+ years in a Quality function in pharma/biotech
• Experience aligned with 21 CFR Part 11/210/211, GMPs, GLP
• Strong data reporting, analysis and QA documentation skills

Responsibilities

• Execute global reporting control and invalid trending programs.
• Extract data from LIMs to support reporting needs.
• Lead continuous improvement activities with sites.
• Author Annual Product Review Laboratory Section and quarterly reports.
• Support new methods, KLIMS implementation, and new capabilities.

Skills

Statistical analysis

Documentation & reporting

Regulatory knowledge

Education

Master's Degree in related field

Bachelor's Degree in related field

High School diploma

Tools

JMP

Minitab

Job description

Planet Group is seeking a Sr. Quality Control (QC) Specialist for an onsite role in California. The position is a 5-month contract with an initial on-site period in Santa Monica, some remote time, and a return to Thousand Oaks.

Responsibilities include data extraction from LIMs, execution of reporting programs, and coordination of continuous improvement with site teams. Proficiency in JMP/Minitab and strong regulatory knowledge (21 CFR Part 11/210/211) are required.