Senior QC Specialist - Lab Compliance & Training

eTeam; Fremont (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

eTeam is seeking a Sr. QC Associate in Fremont, CA for a 12-month, first shift engagement. The role involves leading analytical testing across multiple quality areas, authoring SOPs, and training junior staff in cGMP-compliant practices.

You will work under limited supervision in a multi-product facility with emphasis on quality, safety, and process improvements. Responsibilities include coordinating testing, data review, and process optimization while maintaining rigorous documentation and

Qualifications

• Experience with analytical methodologies across different scientific principles used in Biopharmaceutical manufacturing.
• Ability to maintain focus on detail 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 SOPs and reading/m documenting work per cGMP/GDP standards.
• Ability to work in a high-performing team and collaborate effectively with staff.
• Execution of non-routine analytical methods or processes and trend analysis.

Responsibilities

• Execute and coordinate analytical testing of bulk drug substances and drug products across multiple product lines.
• Coordinate routine-maintained activities and author test methods, specs, plans, reports, forms, and SOPs.
• Train other associates and technicians on methods and compliance.
• Perform testing across several analytical technologies and review data for trends and deviations.
• Document work according to cGMP and cGDP; escalate abnormalities promptly.
• Represent the team in matrix meetings to resolve issues and drive compliant solutions.

Skills

QC experience

Analytical methodologies

Biopharmaceutical analytics

Detail-oriented

Data interpretation

Written and verbal communication

SOPs and cGMP

Independent work

Team collaboration

Process control systems

Education

High School Diploma with cGMP exposure

Associate Degree in science/engineering

Bachelor's Degree in science or engineering

Tools

Computer-based systems

Process control systems

Job description

eTeam is seeking a Sr. QC Associate in Fremont, CA for a 12-month, first shift engagement. The role involves leading analytical testing across multiple quality areas, authoring SOPs, and training junior staff in cGMP-compliant practices.

You will work under limited supervision in a multi-product facility with emphasis on quality, safety, and process improvements. Responsibilities include coordinating testing, data review, and process optimization while maintaining rigorous documentation and