Our client, a Biopharmaceutical company, is looking for a Sr. Quality Control (QC) Specialist for their Walnut Park, CA/ Santa Monica , CA/Remote location.
Responsibilities:
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.
Requirements:
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.
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.