QC Associate I — cGMP Cell & Gene Lab (On‑Site)

Aspen Neuroscience, Inc.; San Diego (CA); Hybrid; USD 28,000 - 33,000; Full time

Benefits offered by this job

Onsite gym

Medical/Dental insurance

Wellness perks

Holidays off

Job summary

Aspen Neuroscience, Inc., located in Torrey Pines, CA, seeks a Quality Control (QC) Associate I to support cGMP manufacturing for a cell and gene therapy program. This on-site role requires flexibility for weekend work and is based in San Diego.

The role covers EM, raw materials, intermediates, drug product and stability testing, with emphasis on accurate data delivery and adherence to GMP standards.

Qualifications

• B.S. Degree in Biology, Cell Biology, Microbiology, Molecular Biology or Biochemistry; Or equivalent related education and experience.
• Experience working in a laboratory (academic or industry) setting and within a cGMP regulated environment is preferred.

Responsibilities

• Perform raw material inspection and sampling.
• Perform EM sampling in aseptic manufacturing environments: total particulate monitoring, active air sampling, surface and personnel monitoring.
• Assist with submission of samples to contract testing laboratories.
• Assist with organizing QC laboratories including equipment calibration.
• Conduct QC tests for raw material, intermediates, drug product, and stability samples.
• Perform test following test protocols and procedures in compliance with quality standards and cGMP regulations applicable to QC laboratory.
• Deliver cGMP compliant testing data and reports.
• Participate in investigation of deviation or out-of-specification results in QC laboratory.

Skills

Attention to detail

MS Office

Initiative

Teamwork

Communication

Flexibility

GMP knowledge

Education

B.S. in Biology

Job description

Aspen Neuroscience, Inc., located in Torrey Pines, CA, seeks a Quality Control (QC) Associate I to support cGMP manufacturing for a cell and gene therapy program. This on-site role requires flexibility for weekend work and is based in San Diego.

The role covers EM, raw materials, intermediates, drug product and stability testing, with emphasis on accurate data delivery and adherence to GMP standards.