QC Analyst - Cell & Gene Therapy (On-Site)

Valid8 Financial, Inc.; San Diego (CA); On-site; USD 28,000 - 33,000; Full time

Benefits offered by this job

Medical/Dental insurance

Onsite gym

Wellness perks

Company holidays

Job summary

Aspen Neuroscience, Inc. in Torrey Pines, CA is seeking a QC Associate I to support cGMP manufacturing through sampling and testing of raw materials, intermediates, drug product and stability samples.

You will participate in environmental monitoring and ensure data integrity in a fast-paced on-site lab. Responsibilities include material inspection, EM sampling in aseptic environments, lab organization, calibration, and investigations of deviations.

Qualifications

• 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, drugproductand stability samples.
• Perform test following test protocols and procedures in compliance with quality standards and cGMP regulationsapplicable 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

Organizational skills

Proficiency in Microsoft Office

Initiative

Teamwork and independence

Communication skills

Flexibility

Knowledge of GMP Regulations

Education

B.S. in Biology/Cell Biology/Microbiology/ Biochemistry

Tools

Microsoft Office Suite

Job description

Aspen Neuroscience, Inc. in Torrey Pines, CA is seeking a QC Associate I to support cGMP manufacturing through sampling and testing of raw materials, intermediates, drug product and stability samples.

You will participate in environmental monitoring and ensure data integrity in a fast-paced on-site lab. Responsibilities include material inspection, EM sampling in aseptic environments, lab organization, calibration, and investigations of deviations.