Senior QC Data & Reporting Specialist (Hybrid)

Unicon Pharma Inc; Santa Monica (CA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Unicon Pharma Inc in Santa Monica, CA seeks a Senior QC Specialist to advance product quality through global reporting, data trending, and continuous improvement. The role collaborates with global QC teams, laboratory operations, and Technical Operations in a fast-paced biopharma environment.

You will apply JMP or Minitab for QC data analysis, support regulatory compliance (GMP/GLP) and health authority inspections, and drive cross-site improvements while working onsite three days a week with

Qualifications

• Masters with 4+ years of quality experience or equivalent.
• Experience in the pharmaceutical/biotechnology industry.
• Familiarity with GMP, GLP, quality systems, and FDA regulations (21 CFR Parts 11, 210, and 211).
• Experience supporting US and international health authority inspections.
• Strong communication, organizational, and time management skills.

Responsibilities

• Execute global reporting, control, and invalid trending programs.
• Extract data from LIMS to support reporting requirements.
• Prepare Annual Product Review laboratory sections and quarterly/biannual trending reports.
• Lead continuous improvement initiatives across sites.
• Support new analytical methods, KLIMS implementation, and laboratory technology enhancements.
• Ensure timely reporting and compliance with procedures and regulatory requirements.
• Apply statistical tools such as JMP or Minitab to analyze QC data.
• Collaborate cross-functionally to improve processes and operational efficiency.

Skills

Communication skills

Time management

Organizational skills

Statistical analysis

Risk management

Cross-functional collaboration

Education

Master’s degree in related field

Bachelor’s degree in related field

High school diploma with 10+ years of quality experience

Tools

JMP

Minitab

Microsoft Office

Job description

Unicon Pharma Inc in Santa Monica, CA seeks a Senior QC Specialist to advance product quality through global reporting, data trending, and continuous improvement. The role collaborates with global QC teams, laboratory operations, and Technical Operations in a fast-paced biopharma environment.

You will apply JMP or Minitab for QC data analysis, support regulatory compliance (GMP/GLP) and health authority inspections, and drive cross-site improvements while working onsite three days a week with