Quality Control Associate Scientist: Validation & QC Impact

GeminiBio; West Sacramento (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

GeminiBio, located in West Sacramento, CA, seeks a Quality Control Associate Scientist to join the Quality Department. The role supports analytical assays, method development, and equipment qualification under supervision.

The ideal candidate holds a Bachelor’s degree in biology/chemistry/biochemistry and 3+ years in ISO-regulated laboratories, with strong communication and problem-solving skills to drive quality improvements.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Biochemistry, or related scientific discipline.
• 3+ years of experience in analytical laboratory within ISO-regulated environment.
• Experience supporting stability studies and report preparation.
• Experience with IQ/OQ/PQ protocols in regulated settings.
• Familiarity with ISO quality systems and document control.

Responsibilities

• Design, develop, and implement new QC processes and procedures.
• Develop and execute analytical methodologies for in-process testing and final product evaluation.
• Support validation activities and equivalency studies under supervision.
• Assist in stability testing protocols and inventory management.
• Participate in investigations of out-of-specification results and quality events.
• Maintain QMS documents and ensure compliance with SOPs.
• Collaborate with cross-functional teams for process improvements.

Skills

Biology

Chemistry

Biochemistry

Analytical laboratory

ISO 13485

GxP

IQ/OQ/PQ

Stability studies

Data analysis

Microsoft Excel

Documentation

Lean Six Sigma

Education

Bachelor’s degree in Biology, Chemistry, Biochemistry, or related

Job description

GeminiBio, located in West Sacramento, CA, seeks a Quality Control Associate Scientist to join the Quality Department. The role supports analytical assays, method development, and equipment qualification under supervision.

The ideal candidate holds a Bachelor’s degree in biology/chemistry/biochemistry and 3+ years in ISO-regulated laboratories, with strong communication and problem-solving skills to drive quality improvements.