Senior Quality Control Associate

Fladger Associates; El Segundo (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Fladger Associates in El Segundo, CA seeks an experienced Sr. Quality Control Specialist onsite for cross-functional support across Technical Operations. The role focuses on quality systems, regulatory compliance, and data-driven reporting in the pharma/biotech field.

You will execute global reporting programs, extract data from LIMS, and lead continuous improvement with sites. You’ll author key quality documents including the Annual Product Review Lab section and quarterly invalid trend

Qualifications

• Master’s or Bachelor’s degree with 4–6+ years in pharma quality function.
• Strong knowledge of 21 CFR Part 11/210/211 and GMP/GLP.
• Experience with risk management and inspections is a plus.
• Ability to adjust workload to changing priorities.

Responsibilities

• Execute global reporting control programs and invalid trending.
• Extract data from LIMS to support reporting requirements.
• Lead continuous improvement activities partnering with sites.
• Author Annual Product Review Laboratory Section.
• Author technical quarterly invalid and biannual control trending reports.
• Interact with laboratory operations on new methods, technology, and KLIMS implementations.
• Meet reporting deadlines and demonstrate time management.
• Improve processes to minimize complexities and optimize operations.
• Proficient with JMP and Minitab; strong MS Office skills.

Skills

Quality systems

21 CFR Part 11/ GMPs GLP

Cross-functional collaboration

Regulatory inspections experience

Education

Master’s degree in quality/regulatory field

Bachelor’s degree in related field

High School Degree with 10+ years’ experience

Tools

JMP

Minitab

Job description

• Excellent employment opportunity for a Sr. Quality Control (QC) Specialist in the El Segundo, CA area. Onsite
• Number of days per week onsite: 3 "collaboration days" of Tuesday, Wednesday and Thursday
• 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.
• 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.

Experience:

• 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.