cGMP Compliance Specialist (Therapeutics)

Houston Methodist; Houston (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Houston Methodist is seeking a cGMP Specialist responsible for adherence to SOPs and regulatory requirements across therapeutics and device manufacturing. The role includes reviewing procedures, verifying equipment and facility cleanliness, proper gowning, accurate labelling, and correct execution of protocols per approved SOPs.

The ideal candidate has a bachelor’s degree (master’s preferred) with about three years of biotech or pharmaceutical experience, familiarity with FDA regulations, and

Qualifications

• Bachelor's degree in science or arts required.
• Master’s degree preferred.
• Three years of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operations.

Responsibilities

• Provide work direction of authorized core users in production or quality control.
• Collaborate with cross-functional teams including research, process development, QA and QC.
• Assist researchers in transitioning their processes to compliant cGMP SOPs and participate in multi-functional project teams as necessary.
• Participate in internal audits and external inspections and report findings to management.

Skills

cGMP compliance

SOP adherence

Regulatory audits

IQ/OQ/PQ validation

Documentation and reporting

Communication skills

Education

Bachelor's degree

Master's degree preferred

Job description

Houston Methodist is seeking a cGMP Specialist responsible for adherence to SOPs and regulatory requirements across therapeutics and device manufacturing. The role includes reviewing procedures, verifying equipment and facility cleanliness, proper gowning, accurate labelling, and correct execution of protocols per approved SOPs.

The ideal candidate has a bachelor’s degree (master’s preferred) with about three years of biotech or pharmaceutical experience, familiarity with FDA regulations, and