Sr. Quality Control (QC) Specialist - Control Trending

VARITE • El Segundo, CA

1d • Hybrid

About The Position

VARITE is seeking a highly motivated Sr. Quality Control (QC) Specialist to support the Product Quality function at a biotechnology company focused on cancer immunotherapy, including genetically engineered autologous CAR T-cell therapy. The role is based in El Segundo, California, and follows a hybrid schedule with three onsite days per week (Tuesday, Wednesday, and Thursday). It is a 10-month contract with a possible extension and a stated pay range of $50.00 to $53.95 per hour on W-2.

The specialist will report to the Director of Analytical Method Lifecycle and Trending and work cross-functionally with global and site-based QC subject-matter experts and other Technical Operations departments. The role supports global control and invalid trending programs, reporting, continuous improvement, and laboratory methods and systems.

Requirements

• One of the following education and experience combinations: master's degree and at least 4 years of experience in a Quality function in the pharmaceutical or biotechnology industry; bachelor's degree and at least 6 years of such experience; or high school degree and at least 10 years of such experience.
• Proficiency with statistical tools such as JMP and/or Minitab.
• Proficiency in Microsoft Office applications.
• Working knowledge of quality systems and regulatory requirements, including 21 CFR Parts 11, 210, and 211.
• Knowledge of Quality Control, GMPs, and GLP.
• Strong written and oral communication skills.
• Self-motivation, attention to detail, and willingness to support other team members.

Nice To Haves

• Experience with gene and cell therapies or the pharmaceutical industry.
• Statistical knowledge in biologics.
• Ability to adjust workload as priorities change.
• Experience with risk management processes.
• Experience with U.S. and international health authority inspections.

Responsibilities

• Execute global reporting control and invalid trending programs.
• Extract data from the LIMS system to support reporting requirements.
• Lead and coordinate continuous improvement activities in partnership with sites.
• Author the laboratory section of the Annual Product Review.
• Author technical quarterly invalid and biannual control trending reports.
• Work with laboratory operations to support new methods, technology, and KLIMS implementation, including ongoing support for new module implementations and installation of new capabilities.
• Meet procedure-defined reporting deadlines using effective organizational, prioritization, and time-management practices.
• Communicate effectively in writing and orally with cross-functional audiences.
• Improve processes to minimize complexity and optimize operational effectiveness.
• Support other team members as needed.

Benefits

• Medical, dental, and vision coverage for eligible employees.
• Participation in a company-sponsored retirement savings plan for eligible employees.
• Legal service plans providing access to attorneys for advice and representation.
• Potential eligibility for an employee referral bonus if a referred candidate is hired.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior