Job Title: Sr. Quality Control (QC) Specialist
Location: Santa Monica, CA, 90404
Duration: 10 months
Shift : Onsite (initially in Santa Monica for the month of November, some remote time, then return to office in Thousand Oaks)
Number of days per week onsite: 3 "collaboration days" of Tuesday, Wednesday and Thursday
Description:
- Everyone is grounded by one common goal - curing cancer.
- Every single day, we seek to establish a direct line between that purpose and our day-to-day work. We are in search of a highly motivated individual to join us as a Sr. Quality Control (QC) Specialist, located at our Santa Monica, California location.
- This role will support the Product Quality function reporting to the Director of Analytical Method Lifecycle and Trending but work cross functionally with global and site-based QC SMEs, and other departments within Technical Operations.
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.
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