Quality Specialist

Company Overview

Southend Pharmacy is a modern 503A compounding pharmacy built on clinical precision, operational clarity, and a human-first approach. Licensed in 35+ states and focused on longevity-aligned therapeutics, we support providers and their patients with precision in compounding and transparent processes. Southend Pharmacy operates at the intersection of innovation, ambition, and clinical excellence—blending precision, clarity, and compassionate support to help providers deliver patient-centered, clinically guided care across every step of the treatment journey.

Job Summary

The Quality Specialist will be responsible for but not limited to ensuring compliance with regulatory standards, maintaining high-quality standards for compounded medications, and supporting operational excellence. This role is critical for the quality assurance (QA) and quality control (QC) of the company, with a primary focus on the Batch Release process, environmental monitoring, and investigational writing.

Key Responsibilities

• Refine 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 <795>, <797>, and <800> 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.

• Monitor, calibrate, and validate 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 

Required

• High school diploma.

• Must hold an 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 <795>, <797>, and <800> 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

• 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

• This role requires 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.

• Ample opportunities for professional development and career growth.

Southend Pharmacy is unable to offer visa sponsorship at this time. Candidates must be legally authorized to work in the United States without current or future sponsorship.

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. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

If you have any questions or require accommodations during the application process, please contact [email protected].