Senior Quality Control Research Associate — Data-Driven QC

Lancesoft; El Segundo (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Lancesoft is seeking a Sr. Quality Control (QC) Specialist in California to support the Product Quality function. The role reports to the Director of Analytical Method Lifecycle and Trending and collaborates with global QC SMEs and other Technical Operations teams.

Responsibilities include leading reporting, data extraction from LIMs, and driving continuous improvement while ensuring compliance with GMP/GLP and 21 CFR Part 11. Strong analytical and communication skills required.

Qualifications

• Master's Degree + 4+ years in pharma/biotech quality
• Bachelor's Degree + 6+ years in pharma/biotech quality
• High School + 10+ years in pharma/biotech quality

Responsibilities

• Execute global reporting control and invalid trending programs.
• Extract LIMs data to support reporting requirements.
• Lead continuous improvement activities with sites.
• Prepare Annual Product Review Laboratory Section.
• Prepare quarterly invalid and biannual control trending reports.
• Collaborate with lab operations on new methods and KLIMS implementations.
• Meet reporting deadlines with strong organization and time management.
• Demonstrate strong written and oral communication across cross-functional audiences.
• Adhere to GMP/GLP and 21 CFR Part 11 compliance.

Skills

Quality

Data analysis

Attention to detail

Education

Master's Degree in quality or related field

Bachelor's Degree in quality or related field

High School Diploma with 10+ years in quality

Tools

JMP

Minitab

Microsoft Office

KLIMS

Job description

Lancesoft is seeking a Sr. Quality Control (QC) Specialist in California to support the Product Quality function. The role reports to the Director of Analytical Method Lifecycle and Trending and collaborates with global QC SMEs and other Technical Operations teams.

Responsibilities include leading reporting, data extraction from LIMs, and driving continuous improvement while ensuring compliance with GMP/GLP and 21 CFR Part 11. Strong analytical and communication skills required.