Sr. Quality Control (QC) Specialist

Unicon Pharma Inc; Santa Monica (CA); Hybrid; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Communication skills

Time management

Organizational skills

Statistical analysis

Risk management

Cross-functional collaboration

Ausbildung

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

Jobbeschreibung

Job Title: Sr. Quality Control (QC) Specialist

Work Arrangement: Onsite 3 days per week (Tuesday–Thursday), with some remote flexibility

Job Summary

Seeking a highly motivated Senior QC Specialist to support Product Quality, focusing on global reporting, invalid result trending, control trending, and continuous improvement initiatives. The role involves cross-functional collaboration with global QC teams, laboratory operations, and Technical Operations.

Key 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.

Basic Qualifications

• Master’s degree with 4+ years of Quality experience, or
• Bachelor’s degree with 6+ years of Quality experience, or
• High school diploma with 10+ years of Quality experience.
• Experience in the pharmaceutical or biotechnology industry.

Preferred Qualifications

• Experience in cell and gene therapy or biologics.
• Knowledge of statistical analysis and risk management.
• 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.
• Proficiency in Microsoft Office and statistical software.