Senior QC Specialist, Biopharma Analytics - Fremont (Onsite)

Spectraforce Technologies, Inc.; Fremont (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Senior QC Associate to join the onsite team in Fremont, CA. The role focuses on coordinating analytical testing across multiple QC areas and ensuring adherence to cGMP procedures in a high-complexity biopharmaceutical environment.

The candidate will perform and supervise analytical methods, train staff, review data, and contribute to quality documentation while maintaining strict compliance and safety standards.

Qualifications

• Experience with analytical methodologies relevant to Biopharmaceutical manufacturing.
• Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first-time mindset.
• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
• Proven experience with technical review, analysis, and interpretation of scientific data.
• Strong written and verbal communication skills.
• Experience with computer-based systems and process control systems.
• Ability to read and understand SOPs and document work in a written format applying cGMP/GDP standards.

Responsibilities

• Coordinates routine-maintained activities and is responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs).
• Trains other associates and technicians on methods and processes.
• Executes independently, with adequate training, three to five analytical testing methods with different analytical principles under minimum oversight by qualified staff.
• Manages and reviews fundamental tasks such as buffer prep, TCU maintenance, and cleaning.
• Documents work according to cGMP and cGDP.
• Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.

Skills

Analytical testing

Biopharma QC

cGMP compliance

Method development

Documentation

Training others

Detail-oriented

Team collaboration

Education

Bachelor's degree in science or engineering

Associate degree (4+ years)

High school diploma (6+ years)

Job description

Spectraforce Technologies, Inc. is seeking a Senior QC Associate to join the onsite team in Fremont, CA. The role focuses on coordinating analytical testing across multiple QC areas and ensuring adherence to cGMP procedures in a high-complexity biopharmaceutical environment.

The candidate will perform and supervise analytical methods, train staff, review data, and contribute to quality documentation while maintaining strict compliance and safety standards.