Quality Control Research Associate - III*

Spectraforce Technologies, Inc.; San Mateo (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Sr. Quality Control (QC) Specialist for a 10-month engagement in Santa Monica, CA.

The role supports the Product Quality function and collaborates with global QC SMEs and Technical Operations to drive data reporting, method support, and continuous improvement. Required qualifications include a Master’s degree with 4+ years of QA experience in pharma/biotech or a Bachelor's with 6+ years (or HS with 10+ years).

Qualifications

• Master's Degree with 4+ years in a QA function in pharma/biotech OR Bachelor's with 6+ years OR High School with 10+ years in QA in pharma/biotech.

Responsibilities

• Execute global reporting control and invalid trending programs.
• Extract data from LIMS to support reporting requirements.
• Lead continuous improvement activities with sites.
• Author Annual Product Review Laboratory Section and quarterly invalid reports.
• Ensure compliance with 21 CFR Part 11/210/211, GMP/GLP.

Skills

JMP

Minitab

LIMS

Microsoft Office

GMP/GLP

Education

Master's degree in a Quality function

Bachelor's degree in a Quality function

High School Diploma with 10+ years of QA experience

Tools

LIMS systems

Job description

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.