Quality Systems Lead – GMP, CAPA & Audit Expert

JOHNSON SERVICE GROUP; Carlsbad (CA); On-site; USD 50,000 - 55,000; Full time

Job summary

Johnson Service Group is seeking a Quality Systems Specialist for a biotech manufacturing company in Carlsbad, CA. The role focuses on investigations, root-cause analyses, CAPAs, and maintaining FDA, cGMP, ISO, and ICH compliance in a sterile drug product environment.

Direct Hire, onsite, with pay ranging $36-$40 per hour. The ideal candidate has at least four years of GMP-regulated experience and strong technical writing and cross-functional collaboration skills.

Qualifications

• Experience leading investigations, root-cause analyses, and CAPAs in GMP-regulated environments.
• Solid knowledge of FDA, cGMP, ISO, and ICH guidelines.
• Strong technical writing and cross-functional collaboration skills.

Responsibilities

• Lead thorough investigations into batch deviations, nonconformances, and product failures.
• Investigate customer complaints by reviewing production records and quality data.
• Perform root-cause analyses and develop CAPAs; monitor CAPA effectiveness.

Skills

Investigation skills

Root-cause analysis

CAPA management

Regulatory knowledge

Technical writing

Communication

Education

Bachelor's degree in biology/chemistry/engineering/life sciences

Tools

MasterControl

NetSuite

Job description

Johnson Service Group is seeking a Quality Systems Specialist for a biotech manufacturing company in Carlsbad, CA. The role focuses on investigations, root-cause analyses, CAPAs, and maintaining FDA, cGMP, ISO, and ICH compliance in a sterile drug product environment.

Direct Hire, onsite, with pay ranging $36-$40 per hour. The ideal candidate has at least four years of GMP-regulated experience and strong technical writing and cross-functional collaboration skills.