Pharma QA Specialist I: Batch Release & Compliance

Sovereign Pharmaceuticals; Fort Worth (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Sovereign Pharmaceuticals in Fort Worth, TX seeks a QA Specialist I to support batch release by reviewing and approving batch-related docs, maintaining training records, and issuing batch records in line with production schedules. The role emphasizes compliance with FDA and 21 CFR Parts 4, 11, 210, 211, and 820, along with attention to detail, strong organization, and effective communication across cross-functional teams.

Core hours are M-F 8:00-4:30 with some flexibility as needed.

Qualifications

• High School diploma or equivalent required.
• 3–4 years of experience in a cGMP pharmaceutical manufacturing environment.
• Experience with drug product manufacturing processes in a cGMP environment.
• Knowledge of pharmaceutical regulations (i.e., 21 CFR Parts 4, 11,210, and 211, as well as 820).
• Proficient in Microsoft Office applications.

Responsibilities

• Maintains and documents individual training records.
• Issues Manufacturing and Packaging Batch Records to Production in alignment with the production schedule.
• Reviews raw material and Events Data Summaries.
• Ensures and maintains FDA compliance with FDA 21 CFR Parts 4, 11,210,211, and 820.
• Ability to monitor and report on tasks, goals, and objectives.
• Performs other tasks as assigned.

Skills

Simple math

Attention to detail

Good organizational skills

Ability to recognize and solve problem

Time management

Dependable

Excellent written and oral comms

Education

High School diploma or equivalent

3–4 years cGMP pharma manufacturing experience

Experience with 21 CFR Parts 4,11,210,211,820

Associate degree preferred

Tools

Microsoft Office

Job description

Sovereign Pharmaceuticals in Fort Worth, TX seeks a QA Specialist I to support batch release by reviewing and approving batch-related docs, maintaining training records, and issuing batch records in line with production schedules. The role emphasizes compliance with FDA and 21 CFR Parts 4, 11, 210, 211, and 820, along with attention to detail, strong organization, and effective communication across cross-functional teams.

Core hours are M-F 8:00-4:30 with some flexibility as needed.