Quality Control Research Associate - III

Lancesoft; El Segundo (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Lancesoft is seeking a Sr. Quality Control (QC) Specialist in California to support the Product Quality function. The role reports to the Director of Analytical Method Lifecycle and Trending and collaborates with global QC SMEs and other Technical Operations teams.

Responsibilities include leading reporting, data extraction from LIMs, and driving continuous improvement while ensuring compliance with GMP/GLP and 21 CFR Part 11. Strong analytical and communication skills required.

Qualifications

• Master's Degree + 4+ years in pharma/biotech quality
• Bachelor's Degree + 6+ years in pharma/biotech quality
• High School + 10+ years in pharma/biotech quality

Responsibilities

• Execute global reporting control and invalid trending programs.
• Extract LIMs data to support reporting requirements.
• Lead continuous improvement activities with sites.
• Prepare Annual Product Review Laboratory Section.
• Prepare quarterly invalid and biannual control trending reports.
• Collaborate with lab operations on new methods and KLIMS implementations.
• Meet reporting deadlines with strong organization and time management.
• Demonstrate strong written and oral communication across cross-functional audiences.
• Adhere to GMP/GLP and 21 CFR Part 11 compliance.

Skills

Quality

Data analysis

Attention to detail

Education

Master's Degree in quality or related field

Bachelor's Degree in quality or related field

High School Diploma with 10+ years in quality

Tools

JMP

Minitab

Microsoft Office

KLIMS

Job description

Job Title: Sr. Quality Control (QC) Specialist

Number of days per week onsite: 3 "collaboration days" of Tuesday, Wednesday and Thursday

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). 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.