QA Specialist I: Batch Release & Compliance

Alora Pharmaceuticals, LLC.; Fort Worth (TX); On-site; USD 60,000 - 75,000; Full time

Job summary

Alora Pharmaceuticals, LLC. seeks a QA Specialist I in Fort Worth, TX to support batch release activities and ensure FDA compliance (21 CFR parts 4, 11, 210, 211, and 820). The role reviews batch records and issues manufacturing and packaging records in line with production schedules.

Candidates should have a high school diploma, 3–4 years in a cGMP pharmaceutical environment, strong attention to detail, and good communication for cross-functional collaboration.

Qualifications

• High school diploma or equivalent.
• 3–4 years in a cGMP pharmaceutical manufacturing environment.
• Experience/knowledge of drug product manufacturing processes in a cGMP environment.
• Ability to exercise judgment with defined procedures.
• Knowledge of pharmaceutical regulations (21 CFR Parts 4, 11, 210, 211, 820).
• Proficient in Microsoft Office.
• Demonstrated ability to plan and work independently with follow-up.

Responsibilities

• Review and approve batch records.
• Issue Manufacturing and Packaging Batch Records to Production per schedule.
• Review and approve raw material and Events Data Summaries.
• Maintain training records and ensure compliance with FDA regulations.

Skills

Math

Attention to detail

Organizational skills

Problem solving

Time management

Dependable

Communication skills

Education

High school diploma

Associate degree preferred

Tools

Microsoft Office

Job description

Alora Pharmaceuticals, LLC. seeks a QA Specialist I in Fort Worth, TX to support batch release activities and ensure FDA compliance (21 CFR parts 4, 11, 210, 211, and 820). The role reviews batch records and issues manufacturing and packaging records in line with production schedules.

Candidates should have a high school diploma, 3–4 years in a cGMP pharmaceutical environment, strong attention to detail, and good communication for cross-functional collaboration.