Quality Assurance Specialist

POSITION OVERVIEW:

The Quality Assurance Specialist strengthens site quality oversight, product integrity, and operational readiness across Empower’s compounding and manufacturing operations. In a hyper-growth, highly regulated 503A/503B environment, this individual contributor leads routine walkthroughs, conducts internal audits, and maintains accurate quality records that support safe, consistent medications. The role partners with site business units and regulatory teams to investigate deviations, assess risks, and implement corrective and preventive actions. Ownership includes 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 quickly. By connecting daily quality activities to broader operational priorities, the specialist identifies practical improvements, communicates issues clearly, and reinforces current Good Manufacturing Practices (cGMP) compliance without compromising patient safety or quality.

RESPONSIBILITIES:

Site Quality Oversight

• Site Walkthroughs: Lead routine walkthroughs of compounding and manufacturing areas to assess adherence to regulatory requirements, internal standards, and approved procedures.
• Risk Assessment: Collaborate with site business units and regulatory teams to assess quality risks and recommend actions that protect product integrity.
• Quality Training: Support training on regulatory expectations, internal quality metrics, and procedures to strengthen employee understanding and consistent adherence to requirements.

Investigations and Quality Improvement

• Deviation Investigations: Support cross-functional deviation investigations by reviewing relevant documentation and applying root cause analysis tools to help identify underlying quality issues.
• Corrective Actions: Implement assigned corrective and preventive actions arising from internal or external audits, coordinating with stakeholders to address identified deficiencies.
• Process Improvement: Identify practical opportunities to improve quality oversight and documentation workflows, partnering with colleagues to strengthen accuracy, consistency, and efficiency.

Documentation and Inspection Readiness

• Quality Records: Maintain complete, accurate quality records under enterprise Quality Assurance oversight, meeting regulatory requirements and internal policies for timely closure and archiving.
• Internal Audits: Conduct internal audits of site operations and documentation, record findings clearly, and communicate compliance gaps to relevant stakeholders.
• Inspection Support: Prepare inspection readiness documentation and support regulatory inspections by organizing quality records and providing accurate information within assigned responsibilities.

KNOWLEDGE AND SKILLS:

• Knowledge of current Good Manufacturing Practices, Food and Drug Administration requirements, and United States Pharmacopeia standards applicable to compounding and manufacturing.
• Ability to review quality documentation for accuracy and completeness, understand batch record flow, and maintain organized records through closure and archiving.
• Skill in root cause analysis, quality risk assessment, and process improvement methods to support investigations and implement corrective and preventive actions.
• Clear communication and collaborative problem-solving skills, with working knowledge of Microsoft Office tools for organizing quality information and coordinating cross-functional activities.

EXPERIENCE AND QUALIFICATIONS: 

• At least 3 years of quality experience within pharmaceutical manufacturing, including practical application of cGMP principles and regulatory compliance requirements required.
• Bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline, or equivalent practical work experience relevant to pharmaceutical quality assurance required.
• Demonstrated accuracy in documentation review, understanding of batch record flow, working knowledge of Microsoft Office, and effective cross-functional communication required.
• Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA) certification supporting expertise in auditing or quality improvement strongly preferred.