Pharma QA Specialist I — Batch Release

Sovpharm; Fort Worth (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Sovpharm in Fort Worth, TX is seeking a QA Specialist I to support the Batch Release department by reviewing and approving batch documentation and maintaining training records. You will issue Manufacturing and Packaging Batch Records aligned with production schedules, and ensure compliance with FDA regulations including 21 CFR Parts 4, 11, 210, 211, and 820.

Strong attention to detail and organization are essential.

Qualifications

• 3–4 years in a cGMP pharmaceutical manufacturing environment.
• Experience with drug product manufacturing processes in a cGMP environment.
• Knowledge of FDA regulations 21 CFR Parts 4, 11, 210, 211, and 820.
• Proficiency with Microsoft Office applications.
• Ability to plan, work independently, and follow up on tasks.

Responsibilities

• Review and approve batch-related documentation.
• Issue Manufacturing and Packaging Batch Records to Production.
• Maintain training records.
• Ensure compliance with FDA regulations (FDA 21 CFR Parts 4, 11, 210, 211, 820).
• Monitor and report on assigned tasks and objectives.
• Perform other tasks as assigned.

Skills

Attention to detail

Time management

Organizational skills

Problem solving

Communication skills

Dependability

Education

High School diploma or equivalent

Associate degree preferred

Job description

Sovpharm in Fort Worth, TX is seeking a QA Specialist I to support the Batch Release department by reviewing and approving batch documentation and maintaining training records. You will issue Manufacturing and Packaging Batch Records aligned with production schedules, and ensure compliance with FDA regulations including 21 CFR Parts 4, 11, 210, 211, and 820.

Strong attention to detail and organization are essential.