Quality Control (QC) Associate I

Aspen Neuroscience•San Diego, CA

1d•$28 - $33•Onsite

About The Position

The Quality Control (QC) Associate I will contribute to general QC operations and testing in support of current Good Manufacturing Practice (cGMP) manufacturing for an innovative cell and gene therapy program. This individual will participate in Environmental Monitoring (EM), raw material, intermediates, drug product, and stability testing program. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

Requirements

B.S. Degree in Biology, Cell Biology, Microbiology, Molecular Biology or Biochemistry; Or equivalent relevant education and experience.
Experience working in a laboratory (academic or industry) setting and within a cGMP regulated environment is preferred.
Attention to detail and organizational skills: Exceptional ability to manage tasks efficiently and maintain high levels of accuracy.
Proficiency in Microsoft software: Demonstrated experience with Microsoft Office Suite and other Microsoft applications.
Initiative in a dynamic environment: Strong self-starter with the ability to thrive in a fast-paced setting.
Teamwork and independence: Capable of collaborating effectively within a team and working independently after initial training.
Communication skills: Excellent written and verbal communication abilities.
Flexibility: Willingness to work flexible hours, including occasional weekends, to support production needs.
Knowledge of GMP Regulations: Basic familiarity with Good Manufacturing Practices (GMP) and industry standards

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.