Senior QC Analyst – Analytical Methods & Compliance

Aequor; Fremont (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Aequor in Fremont, CA is seeking a SR QC Associate to lead analytical testing across multiple technologies in a multi-product facility. You will coordinate raw material testing, write and review SOPs, and train other associates while ensuring cGMP compliance and quality systems.

The role emphasizes independent work, adherence to procedures, and collaboration with cross-functional teams to drive quality improvements in biopharmaceutical manufacturing.

Qualifications

• Experience in cGMP regulated industry is required.
• Analytical methodologies across multiple principals relevant to Biopharmaceutical manufacturing.
• Detail-oriented work in a complex technical setup with a quality-first mindset.
• Strong understanding of analytical chemistry and testing in biopharmaceuticals.
• Proven ability to review, analyze and interpret scientific data.
• Strong written and verbal communication skills.
• Experience with computer-based systems.
• Ability to read SOPs and document work per cGMP/GDP.
• Team collaboration and cross-functional work.
• Proficiency in 3-5 analytical methods with trend analysis.

Responsibilities

• Execute and coordinate analytical testing of bulk drug substances and drug products.
• Coordinate raw material sampling and testing, including clean rooms as applicable.
• Author test methods, specs, plans, reports, forms, SOPs and other compliance documents.
• Train associates and technicians on methods and processes.
• Perform testing across multiple analytical technologies and review data for trends and deviations.
• Maintain training and lead group training on compliance topics.
• Identify process improvements and root causes for issues and escalate appropriately.
• Represent team in cross-functional meetings to drive solutions.

Skills

QC experience

Biopharma analysis

Analytical chemistry

Detail oriented

Written communication

Data review

Team collaboration

Independent work

Method validation

Education

High School Diploma with six years cGMP

Associate Degree with four years cGMP

Bachelor's degree in science/engineering with two+ years cGMP

Tools

Process control systems

Job description

Aequor in Fremont, CA is seeking a SR QC Associate to lead analytical testing across multiple technologies in a multi-product facility. You will coordinate raw material testing, write and review SOPs, and train other associates while ensuring cGMP compliance and quality systems.

The role emphasizes independent work, adherence to procedures, and collaboration with cross-functional teams to drive quality improvements in biopharmaceutical manufacturing.