Sr. Quality Control (QC) Specialist Pay: $50 - $53.96 per hour Duration: 5 months Location: Onsite (initially in Santa Monica for the month of November, some remote time, then return to office in Thousand Oaks) 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. • 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: • Master's Degree and 4+ years' experience in a Quality function in the pharmaceutical or biotechnology industry • OR Bachelor's 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.