GMP QA Associate II - Quality & Compliance Champion

BioSpace; San Diego (CA); On-site; USD 76,000 - 92,000; Full time

Benefits offered by this job

Medical/Dental insurance

Onsite gym

Paid time off

Wellness perks

Holidays

Job summary

Aspen Neuroscience, Inc. in San Diego (Torrey Pines on-site) is seeking a Quality Assurance Associate II to ensure cGMP compliant materials, processes, and documentation.

The role involves review of batch records, deviations, CAPAs, and audit support, with cross-functional collaboration across Manufacturing, QC, Facilities, and Supply Chain. The ideal candidate has a biology-related degree and 2+ years GMP experience, aseptic technique, and familiarity with cleanroom environments.

Qualifications

• Bachelor’s degree in biological sciences or relevant field; minimum 2 years GMP manufacturing experience.
• Experience in regulated environments (GMP, GLP) is required; cell therapies a plus.
• Aseptic technique, drug safety testing, and environmental monitoring experience a plus.
• Experience in ISO 5/ISO7 clean rooms is a plus.

Responsibilities

• Review batch records, analytical data, deviations, CAPAs, and change controls to support disposition.
• Perform independent review of GMP documentation and correct errors.
• Support line clearance, housekeeping, and manufacturing observations for compliance.
• Assist in releasing raw materials, equipment, and supplier qualification activities.
• Participate in internal and external audits and quality investigations.
• Draft and revise SOPs and documentation per control practices.
• Collaborate with Manufacturing, QC, Facilities, and Supply Chain to meet quality goals.

Skills

GMP compliance

Quality systems

Documentation review

Problem solving

Attention to detail

Cross-functional collaboration

Communication skills

Adaptability

Technical proficiency

Cleanroom operations

Education

Bachelor’s degree in biological sciences or relevant field

Tools

Microsoft Office

Electronic quality management systems

Job description

Aspen Neuroscience, Inc. in San Diego (Torrey Pines on-site) is seeking a Quality Assurance Associate II to ensure cGMP compliant materials, processes, and documentation.

The role involves review of batch records, deviations, CAPAs, and audit support, with cross-functional collaboration across Manufacturing, QC, Facilities, and Supply Chain. The ideal candidate has a biology-related degree and 2+ years GMP experience, aseptic technique, and familiarity with cleanroom environments.