Sr. Quality Control (QC) Specialist # 26-26966

USTech Solutions • Santa Monica, CA

1d • Hybrid

About The Position

The Sr. Quality Control (QC) Specialist supports the Product Quality function and reports to the Director of Analytical Method Lifecycle and Trending. The role works cross-functionally with global and site-based QC subject matter experts and other Technical Operations departments. The position is initially onsite in Santa Monica, California, for the month of November, includes some remote time, and then returns to the office in Thousand Oaks, California. The assignment is for 10 months, with a possible extension.

Requirements

• 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 such experience; or high school degree and 10+ years of such experience.
• Highly effective written and oral communication skills for addressing a cross-functional audience.
• Self-motivated and detail-oriented, with a willingness to support other team members.
• 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 Part 11/210/211, Quality Control, GMPs, and GLP.

Nice To Haves

• Experience with gene and cell therapies or the pharmaceutical industry.
• Statistical knowledge in biologics.
• Ability to adjust workload based on changing priorities.
• Experience in Risk Management processes.
• Experience with US 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 Annual Product Review Laboratory Section.
• Author technical quarterly invalid and biannual control trending reports.
• Work with laboratory operations to support new methods, technology, KLIMS implementation, new module implementations, and installation of new capabilities.
• Meet reporting deadlines defined by procedure.
• Improve processes to minimize complexity and optimize operational effectiveness.

What This Job Offers

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