Quality Lab Analyst I – cGMP Compliance

Creative Testing Solutions, Inc.; San Marcos (TX); On-site; USD 60,000 - 95,000; Full time

Job summary

Creative Testing Solutions, Inc. in Texas seeks a Quality Specialist to ensure proper testing, data integrity, and cGMP conformance. You will review QC data, approve results for release to laboratory customers, and maintain rigorous documentation and confidentiality across departments.

The role requires a Bachelor’s degree with 2–4+ years of cGMP experience depending on level, and involves audits, CAPA handling, and collaboration with cross-functional teams in a lab environment.

Qualifications

• Bachelor’s degree required.
• 2+ years in a cGMP environment for Quality Specialist II; 4+ years for Quality Specialist III, with training experience preferred.
• Experience with laboratory production processes and documentation practices.

Responsibilities

• Review and approve QC and verifications for routine testing of biological samples.
• Approve final test results for release to customers.
• Maintain records and documentation per SOPs and GMP regulations.
• Ensure donor, patient and employee confidentiality.
• Assist with internal and external audits and CAPA investigations.
• Support audits and performance improvement initiatives.

Skills

Critical thinking

Problem solving

Confidentiality

Computer skills

Windows

Teamwork

Instruction following

Education

Bachelor’s degree

Tools

Laboratory Information System

Microsoft Excel

Job description

Creative Testing Solutions, Inc. in Texas seeks a Quality Specialist to ensure proper testing, data integrity, and cGMP conformance. You will review QC data, approve results for release to laboratory customers, and maintain rigorous documentation and confidentiality across departments.

The role requires a Bachelor’s degree with 2–4+ years of cGMP experience depending on level, and involves audits, CAPA handling, and collaboration with cross-functional teams in a lab environment.