Senior QC Specialist — Biotech Quality & Analytics Lead

Rangam; Thousand Oaks (CA); Hybride; USD 85 000 - 125 000; Plein temps

Résumé du poste

Rangam seeks a Sr. Quality Control (QC) Specialist in Santa Monica, CA to support Product Quality. You will report to the Director of Analytical Method Lifecycle and Trending and work cross-functionally with QC SMEs and Technical Operations.

Responsibilities include leading reporting programs, extracting data from LIMS, coordinating improvements, and authoring Annual Product Review Laboratory Section and quarterly trend reports. Strong knowledge of GMP, GLP, and 21 CFR Part 11 is required.

Qualifications

• Master’s degree with 4+ years in pharma/biotech quality or related field.
• Bachelor’s degree with 6+ years in pharma/biotech quality, or High School with 10+ years.
• Strong knowledge of GMP, GLP, and 21 CFR Part 11/210/211.

Responsabilités

• Execute global reporting control and invalid trending programs.
• Extract data from LIMS to support reporting requirements.
• Lead continuous improvement activities with sites.
• Prepare Annual Product Review Laboratory Section.
• Prepare technical quarterly invalid and biannual trend reports.
• Support new methods, tech, and KLIMS implementation in labs.

Connaissances

Detail oriented

Cross-functional collaboration

Written & oral communication

Analytical thinking

Formation

Master’s Degree

Bachelor’s Degree

High School Degree

Outils

JMP

Minitab

Description du poste

Rangam seeks a Sr. Quality Control (QC) Specialist in Santa Monica, CA to support Product Quality. You will report to the Director of Analytical Method Lifecycle and Trending and work cross-functionally with QC SMEs and Technical Operations.

Responsibilities include leading reporting programs, extracting data from LIMS, coordinating improvements, and authoring Annual Product Review Laboratory Section and quarterly trend reports. Strong knowledge of GMP, GLP, and 21 CFR Part 11 is required.