Sr. Quality Control (QC) Specialist

TekWissen•Santa Monica, CA

1d•Hybrid

About The Position

The Sr. Quality Control (QC) Specialist supports the Product Quality function at the client’s Santa Monica, California location. The role reports to the Director of Analytical Method Lifecycle and Trending and works cross-functionally with global and site-based QC subject matter experts and other Technical Operations departments. The position supports the client’s goal of curing cancer and is a 10-month temporary assignment with a hybrid work arrangement.

Requirements

Master’s degree and 4 or more years of experience in a Quality function in the pharmaceutical or biotechnology industry; or bachelor’s degree and 6 or more years of such experience; or high school degree and 10 or more years of such experience.
Proficiency with statistical tools such as JMP and/or Minitab.
Proficiency with Microsoft Office applications.
Working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11/210/211, Quality Control, GMPs, and GLP.
Strong written and oral communication skills for cross-functional audiences.
Organizational, prioritization, and time management skills to meet reporting deadlines.
Self-motivated and detail-oriented, with 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 based on changing priorities.
Experience with Risk Management processes.
Experience with 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 procedure-defined reporting deadlines using effective organization, prioritization, and time management.
Communicate effectively in writing and orally with cross-functional audiences.
Support other team members and demonstrate a self-motivated, detail-oriented approach.
Improve processes to reduce complexity and optimize operational effectiveness.