QA Specialist III (Pharmaceutical Manufacturing)

Location: Houston, Texas – Onsite
Schedule: Sunday through Thursday, 8:00 AM–5:00 PM

Company

Global life-sciences manufacturing organization operating across more than 30 sites on five continents and producing medicines for patients.

What you will do

• Verify compliance with ISO, cGMP quality systems, FDA regulations, and applicable regulatory guidance.
• Perform QA walkthroughs and partner with Manufacturing and support teams to identify, investigate, and resolve quality issues.
• Provide independent quality oversight and make quality decisions during aseptic manufacturing activities.
• Review and approve Master Batch Records, executed batch records, and GMP documentation supporting manufacturing and product release.
• Support investigations, deviations, environmental monitoring events, laboratory investigations, and root cause analysis.
• Provide on-floor QA support in classified manufacturing environments and contribute to quality-system initiatives and continuous improvement.

Requirements

• Bachelor’s degree in a scientific, technical, engineering, or related discipline.
• At least 5 years of experience in a cGMP-regulated manufacturing environment and related Quality Assurance work.
• Quality Assurance or Quality Control experience in pharmaceutical, biologics, cell therapy, or GMP manufacturing operations.
• Experience with investigations, deviations, root cause analysis, quality systems, GMP documentation, and batch records.
• Knowledge of GMP regulations, including 21 CFR Parts 210, 211, and 820, ISO quality standards, and data integrity requirements.
• Strong critical thinking, communication, technical writing, time management, and cross-functional collaboration skills; ability to become gown-qualified.

Nice to have

• Experience with TrackWise, DMS, SAP, or LIMS.
• Familiarity with aseptic manufacturing, cleanroom operations, and environmental monitoring.

Culture & Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance, short-term and long-term disability insurance, and employee assistance programs.
• Paid time off.