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Job Title: Sr. Quality Control (QC) Specialist
Company: SPECTRAFORCE
Location: El Segundo, CA
Country: USA
Employment Type: On-site
Job Type: Internship
Salary Range: $53.95/hr
About the Role
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.
Key Responsibilities
- Execute global reporting control and invalid trending programs.
- Execute data extraction from LIMs system to support reporting requirements.
- Lead and 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.
- Address a cross-functional audience with highly effective written and oral communication skills.
- Support other team members with a self-motivated, detail-oriented approach.
- Improve processes to minimize complexities and optimize operational effectiveness.
Required Skills
- Proficiency with statistical tools such as JMP and/or Minitab.
- Proficiency in Microsoft Office applications.
- Working knowledge of quality systems.
- 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 Skills
- Working knowledge of regulatory requirements (21 CFR Part 11/210/211).
- Experience in Quality Control, GMPs, and GLP.
- Experience with gene and cell therapies or pharmaceutical industry.
- Statistical knowledge in biologics is a plus.
- Ability to adjust workload based upon changing priorities.
- Experience in Risk Management processes is a plus.
- Experience with US and international health authority inspections is a plus.
Additional Details
- Duration: 10 months.
- Number of days per week onsite: 3 "collaboration days" of Tuesday, Wednesday, and Thursday.
About Us
SPECTRAFORCE delivers staffing and workforce solutions tailored for businesses with precision hiring and recruitment support.