Quality Assurance Specialist - Batch Release & Compliance

Johnson Service Group, Inc.; Carlsbad (CA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Johnson Service Group (JSG) is seeking a Quality Assurance Specialist for our CMO life sciences client in Carlsbad, CA. This role supports quality and compliance within a regulated manufacturing environment, focusing on batch review, lot release, investigations, CAPAs, non-conformances, and client complaints.

The ideal candidate has hands-on experience in cGMP-regulated pharma/biotech or life sciences manufacturing, with strong documentation practices and cross-functional collaboration to

Qualifications

• Bachelor's degree in a Life Sciences discipline or related field preferred.
• Minimum 4 years of relevant Quality Assurance experience.
• Experience in cGMP, 21 CFR 820, ISO 13485, GDP.
• Experience with quality investigations, deviations/non-conformances, CAPAs, and complaint management.
• Experience reviewing batch records and manufacturing documentation.
• Strong problem-solving and attention to detail.

Responsibilities

• Review production batch records and supporting documentation for lot disposition and release.
• Prepare Certificates of Compliance (COC) and review Certificates of Analysis (COA) as required.
• Perform line clearance activities for cGMP manufacturing processes.
• Support manufacturing teams with product quality and compliance issues.
• Initiate, lead, and support investigations involving deviations, non-conformances, CAPAs, and customer/client complaints.
• Manage client complaints through investigation and resolution.
• Perform visual inspection of finished products.
• Support root cause analysis and continuous improvement initiatives.
• Conduct facility walkthroughs to ensure cleanrooms, laboratories, warehouse areas, and other controlled spaces remain compliant.
• Oversee facility and cleanroom cleaning compliance, including required training documentation, cleaning forms, and gowning requalification.
• Maintain accurate documentation in accordance with cGMP and GDP.

Skills

Attention to detail

Problem-solving

Cross-functional collaboration

Strong communication

Independent work

Education

Bachelor's degree in Life Sciences or related field

Tools

MasterControl

NetSuite

Job description

Johnson Service Group (JSG) is seeking a Quality Assurance Specialist for our CMO life sciences client in Carlsbad, CA. This role supports quality and compliance within a regulated manufacturing environment, focusing on batch review, lot release, investigations, CAPAs, non-conformances, and client complaints.

The ideal candidate has hands-on experience in cGMP-regulated pharma/biotech or life sciences manufacturing, with strong documentation practices and cross-functional collaboration to