Quality Engineer: Therapeutics at Collate

San Francisco, California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

N/AIndustries

Requirements

This role requires a Bachelor’s degree in Engineering, preferably Biomedical or Chemical, and a minimum of 5 years of experience in quality engineering, specifically within the pharmaceutical or biotechnology industry. Demonstrated knowledge of GMP regulations, FDA guidelines, and ISO standards is essential, along with experience in process validation, CAPA, and continuous improvement methodologies.

Responsibilities

As a Quality Engineer at Collate, you will be responsible for ensuring the quality and compliance of our therapeutic products throughout the development and manufacturing process. This includes conducting quality audits, investigating deviations and non-conformances, implementing corrective and preventive actions, and supporting process validation activities. You will also contribute to the development and maintenance of quality systems and documentation, as well as collaborating with cross-functional teams to ensure product quality and regulatory compliance.