Sr. Quality Control (QC) Specialist

Planet Pharma; El Segundo (CA); On-site; USD 66,000 - 73,000; Full time

Job summary

Planet Pharma is seeking a Sr. Quality Control (QC) Specialist for our Santa Monica, CA location. You will support Product Quality, report to the Director of Analytical Method Lifecycle and Trending, and work cross-functionally with global QC SMEs and other Technical Operations teams.

Responsibilities include leading reporting and trending, data extraction from LIMs, and authoring key quality reports. Strong statistical skills (JMP/Minitab) and 21 CFR Part 11 knowledge are required.

Qualifications

• Masters degree with 4+ years in pharmaceutical/biotech quality
• Bachelors with 6+ years in quality function
• High School with 10+ years in quality function

Responsibilities

• Execute global reporting control and invalid trending programs.
• Extract data from LIMs system to support reporting requirements.
• Lead/coordinate continuous improvement activities with sites.
• Author Annual Product Review Laboratory Section.
• Author quarterly invalid and biannual control trending reports.
• Support new methods, technology, and KLIMS implementations.
• Meet reporting deadlines per procedure with strong prioritization.
• Communicate clearly with cross-functional teams.
• Improve processes to reduce complexity and optimize operations.
• Utilize JMP and/or Minitab for statistics and data analysis.
• Proficient with Microsoft Office applications.
• Understand and apply 21 CFR Part 11/210/211 quality system regulations.
• Maintain quality control, GMP, and GLP compliance.

Skills

Quality Control

Regulatory compliance

Data analysis

GMP/GLP knowledge

Education

Masters Degree

Bachelors Degree

High School Degree

Tools

JMP

Minitab

Job description

Everyone is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. We are in search of a highly motivated individual to join us as a Sr. Quality Control (QC) Specialist, located at our Santa Monica, California location.

This role will support the Product Quality function reporting to the Director of Analytical Method Lifecycle and Trending but work cross functionally with global and site-based QC SMEs, and other departments within Technical Operations.

Responsibilities

• Execute global reporting control and invalid trending programs, Execute data extraction from LIMs system to support reporting requirements, Lead/coordinate continuous improvement activities partnering with sites. Author Annual Product Review Laboratory Section, Author technical quarterly invalid and biannual control trending reports, Interact with the laboratory operations group to support new methods, technology, and KLIMS implementation and ongoing support for new module implementations and/or installation of new capabilities, Meet reporting deadlines as defined per procedure demonstrating organizational, prioritization, and time management proficiencies, Highly effective written and oral communication skills to address a cross-functional audience, Self-motivated, detail-oriented, and willingness to support other team members, Improve processes to minimize complexities and optimize operational effectiveness, Proficient with statistical tools such as JMP and/or Minitab, Proficient in Microsoft Office application, Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), Quality Control, GMPs, GLP.

Basic Qualifications

• Masters Degree and 4+ years experience in a Quality function in the pharmaceutical or biotechnology industry OR Bachelors Degree and 6+ years experience in a Quality function in the pharmaceutical or biotechnology industry OR High School Degree and 10+ years experience in a Quality function in the pharmaceutical or biotechnology industry.

Preferred Qualifications

• Experience with gene and cell therapies or pharmaceutical industry, Statistical knowledge in biologics is a plus, Able to adjust workload based upon changing priorities, Experience in Risk Management processes a plus, Experience with US and international health authority inspections a plus.

Pay ranges between 48-53/hr based on experience