Quality Specialist

Key Responsibilities

• Rename and expand the batch release program and serve as a primary lead for visual inspection processes to verify product quality prior to distribution.
• Oversee the investigation of quality-related incidents, such as deviations or complaints; perform Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
• Develop and implement QA programs to ensure consistent compliance with USP , , and standards, FDA 503A regulations, and state pharmacy laws.
• Help maintain accurate records of compounding activities and writing/revising SOPs from scratch.
• Conduct regular internal audits of compounding processes and facility operations to ensure all documentation is audit-ready for the State Board of Pharmacy or FDA.
• Train pharmacy staff on aseptic techniques and SOPs; monitor adherence to cleanroom protocols and proper execution of compounding procedures.
• Maintain compounding equipment and cleanroom environments to ensure adherence to sterile compounding standards.
• Train pharmacy staff on quality control procedures, aseptic techniques, and gowning protocols to ensure consistent adherence to best practices.

Qualifications

• High school diploma.
• Active and unencumbered license (Pharmacist, Pharmacy Technician, or Technician Trainee) with the Texas State Board of Pharmacy (TSBP).
• Minimum of 1-2 years of experience in sterile compounding (503A or 503B) with a strong understanding of USP , , and or cGMP standards.
• Expert attention to detail and analytical skills for data trending.
• Proficiency in aseptic techniques and quality management systems.
• Excellent written and verbal communication skills for documentation and staff training.

Preferred Qualifications

• Bachelor’s degree in pharmacy, chemistry, biology, or a related field.
• 1+ year in a dedicated Quality Assurance or compliance-related role.
• Relevant certifications (e.g., Certified Quality Auditor or advanced sterile compounding certification).

Physical Requirements

• Routine presence in cleanroom and laboratory environments.
• Ability to stand for extended periods and perform repetitive motions with hands and arms.
• Ability to follow strict growing procedures and work in controlled environments for extended periods.
• Ability to maintain focus in a typical office/pharmacy environment with moderate noise levels.

Benefits

Salary Range: $70,000 - $75,000 annually.
Comprehensive benefits package including medical, dental, paid time off.
401(k) retirement savings plan.
Eligible for quarterly bonus based on performance.

Benefits

Affordable and ample opportunities for professional development and career growth.

Equal Opportunity Employer Statement

Allia Health Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.