Senior QC Associate: Biopharma Analytics & Compliance

Planet Pharma; Fremont (CA); On-site; USD 41,000 - 52,000; Full time

Job summary

Planet Pharma is seeking a Senior QC Associate to support QC functions across HPLC/CE, potency, impurities, and microbial testing in a multi-product facility. The role involves authoring test methods, plans, and SOPs, training staff, and coordinating analytical testing with minimal supervision.

You will perform and review multiple analytical methods, maintain cGMP compliance, and contribute to process improvements while ensuring quality and safety in operations.

Qualifications

• Must have CSCGMP regulated industry experience.
• Experience with analytical methodologies across multiple scientific principles in biopharmaceuticals.
• Strong attention to detail in complex technical environments with quality-first mindset.
• Solid understanding of analytical testing and chemistry as it relates to biopharmaceuticals.
• Experience with technical review, data analysis, and interpretation of scientific data.
• Excellent written and verbal communication skills.
• Familiarity with computer-based systems and process control systems.
• Able to read and follow SOPs and document work per cGMP/GDP standards.

Responsibilities

• Coordinate analytical testing of bulk drug substances and drug products.
• Author test methods, specifications, plans, reports, forms, and SOPs.
• Train associates on methods and processes.
• Perform 3–5 analytical methods with various principles under supervision.
• Manage routine lab tasks (buffer prep, maintenance, cleaning).
• Identify and implement improvements to lab processes and compliance.
• Document work per cGMP and cGDP, report deviations promptly.
• Maintain safety standards and escalate unsafe situations.
• Maintain lab areas per 5S standards.
• Collaborate cross-functionally and lead training when needed.
• Review data for discrepancies and ensure proper investigations.

Skills

QC Experience

Analytical chemistry

Data interpretation

SOPs documentation

cGMP/GDP compliance

Team collaboration

Independent work

Lab safety

Training others

Biopharmaceuticals

Education

High School Diploma + 6 years

Associate Degree + 4 years

Bachelor’s in science/engineering +2 years

Job description

Planet Pharma is seeking a Senior QC Associate to support QC functions across HPLC/CE, potency, impurities, and microbial testing in a multi-product facility. The role involves authoring test methods, plans, and SOPs, training staff, and coordinating analytical testing with minimal supervision.

You will perform and review multiple analytical methods, maintain cGMP compliance, and contribute to process improvements while ensuring quality and safety in operations.