RCI-GILD-17340 Senior QC Specialist (GMP/ GLP) - Data Trending & Reporting - HYBRID

Rangam; Thousand Oaks (CA); Híbrido; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Detail oriented

Cross-functional collaboration

Written & oral communication

Analytical thinking

Educación

Master’s Degree

Bachelor’s Degree

High School Degree

Herramientas

JMP

Minitab

Descripción del empleo

Number of days per week onsite: 3 "collaboration days" of Tuesday, Wednesday and Thursday

About the Role:

Everyone at the client 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, while working cross-functionally with global and site-based QC SMEs and other departments within Technical Operations.

Responsibilities (include, but are not limited to)

• 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.
• Demonstrate highly effective written and oral communication skills to address a cross-functional audience.
• Be self-motivated, detail-oriented, and willing to support other team members.
• Improve processes to minimize complexities and optimize operational effectiveness.
• Be proficient with statistical tools such as JMP and/or Minitab.
• Be proficient in Microsoft Office applications.
• Maintain working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), Quality Control, GMPs, and GLP.

Basic Qualifications

• Master’s Degree and 4+ years of experience in a Quality function in the pharmaceutical or biotechnology industry; OR
• Bachelor’s Degree and 6+ years of experience in a Quality function in the pharmaceutical or biotechnology industry; OR
• High School Degree and 10+ years of 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.
• Ability to adjust workload based upon changing priorities.
• Experience in Risk Management processes is a plus.
• Experience with U.S. and international health authority inspections is a plus.