Senior Quality Assurance Specialist

Empower Pharmacy•Houston, TX

About The Position

The Senior Quality Assurance Specialist strengthens site quality oversight, inspection readiness, and supplier reliability across Empower Pharmacy’s pharmaceutical manufacturing operations. In a highly regulated 503A/503B environment, this individual contributor leads complex audits, coordinates external assessments, and advances risk-based qualification and monitoring of critical suppliers and service providers. The role owns assigned audit preparation, response coordination, and corrective-action follow-through, protecting product quality and patient safety through accurate documentation and verified effectiveness. The specialist is expected to prioritize strategically, execute with discipline, exercise sound judgment, and adapt as requirements and operational needs evolve. Through cross-functional influence, training, and coaching, the role identifies systemic compliance gaps, strengthens cGMP adherence, and delivers sustainable improvements while ensuring assigned inspection and supplier commitments are completed accurately and on schedule.

Requirements

At least 5 years of quality experience within pharmaceutical manufacturing.
Strong knowledge of cGMP requirements, regulatory compliance, inspection readiness, and risk-based auditing methods applicable to pharmaceutical manufacturing and site quality oversight.
Ability to assess supplier capabilities, compliance history, and quality performance, and translate business and patient risks into qualification, monitoring, and escalation decisions.
Proficiency in root-cause analysis tools, corrective action evaluation, documentation review, and batch record flow; working knowledge of Microsoft Office tools.
Clear written and verbal communication, cross-functional influence, and coaching skills to coordinate subject-matter experts, explain complex findings, and sustain remediation commitments.
Bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline, or equivalent work experience demonstrating relevant quality expertise.
Experience leading audits or inspection preparation, coordinating cross-functional responses, and following corrective actions through implementation and documented verification of effectiveness.

Nice To Haves

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

Responsibilities

Lead preparation and execution for regulatory inspections, customer audits, and external assessments; coordinate subject-matter experts, accurate responses, and timely completion of commitments.
Develop risk-based internal audit plans, lead complex audits, evaluate systemic compliance risks, and prepare reports documenting findings and required actions.
Lead inspection-readiness assessments to identify systemic gaps and emerging compliance risks, prioritize remediation, and align cross-functional actions with site needs.
Lead risk-based qualification, auditing, and approval of critical suppliers and service providers by evaluating capabilities, compliance history, and business and patient risks.
Monitor supplier quality performance and compliance trends, identify emerging risks, and recommend supplier status changes based on documented assessment findings.
Lead investigations into significant supplier deficiencies and quality events, determining whether supplier corrective action requests (SCARs) or escalation are required.
Evaluate root-cause analyses and corrective action plans, oversee implementation, and verify effectiveness to support sustainable resolution of audit findings and supplier issues.
Review quality documentation for accuracy and completeness, using batch record knowledge and Microsoft Office tools to support audit preparation and reporting.
Deliver training and coaching on compliance gaps and remediation requirements to strengthen cross-functional understanding, execution discipline, and accountability for commitments.