Quality Control Research Associate - III*

Job Title: Sr. Quality Control (QC) Specialist
Location: El segundo, CA
Duration: 10 months
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.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. The pay rate for this position is $53.95/hr.