Quality Assurance Specialist

Empower Pharmacy•Houston, TX

About The Position

The Quality Assurance Specialist strengthens site quality oversight, product integrity, and operational readiness across Empower Pharmacy’s compounding and manufacturing operations. In a highly regulated 503A/503B environment, this individual contributor leads routine walkthroughs, conducts internal audits, and maintains accurate quality records supporting safe, consistent medications. The role partners with site business units and regulatory teams to investigate deviations, assess risks, and implement corrective and preventive actions. The specialist is responsible for timely documentation closure and archiving, inspection readiness preparation, and support for employee quality training. Success requires disciplined execution, sound judgment, attention to detail, and the ability to learn evolving requirements. The role identifies practical improvements, communicates issues clearly, and reinforces current Good Manufacturing Practices (cGMP) compliance while protecting patient safety and product quality.

Requirements

At least 3 years of quality experience within pharmaceutical manufacturing, including practical application of cGMP principles and regulatory compliance requirements.
Bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline, or equivalent practical work experience relevant to pharmaceutical quality assurance.
Accuracy in documentation review and understanding of batch record flow.
Working knowledge of Microsoft Office.
Effective cross-functional communication skills.
Knowledge of cGMP, FDA requirements, and USP standards applicable to compounding and manufacturing.
Ability to maintain organized quality records through closure and archiving.
Skill in root cause analysis, quality risk assessment, and process improvement methods.

Nice To Haves

Certified Quality Auditor (CQA) certification.
Certified Quality Improvement Associate (CQIA) certification.

Responsibilities

Lead routine walkthroughs of compounding and manufacturing areas to assess adherence to regulatory requirements, internal standards, and approved procedures.
Collaborate with site business units and regulatory teams to assess quality risks and recommend actions that protect product integrity.
Support training on regulatory expectations, internal quality metrics, and procedures.
Support cross-functional deviation investigations by reviewing documentation and applying root cause analysis tools.
Implement assigned corrective and preventive actions arising from internal or external audits, coordinating with stakeholders to address deficiencies.
Identify practical opportunities to improve quality oversight and documentation workflows.
Maintain complete and accurate quality records in accordance with regulatory requirements and internal policies, including timely closure and archiving.
Conduct internal audits of site operations and documentation, record findings, and communicate compliance gaps to stakeholders.
Prepare inspection-readiness documentation and support regulatory inspections by organizing quality records and providing accurate information within assigned responsibilities.