Quality Control Specialist 503B

Position Summary:

The Quality Control Specialist safeguards product integrity and regulatory compliance, directly impacting patient safety, operational reliability, and Empower’s reputation in a highly regulated 503A/503B environment. This role owns end-to-end quality control activities including testing, data analysis, deviation investigation, and documentation, ensuring timely release of materials and products. Leveraging AI as a force multiplier, the specialist enhances testing precision, accelerates root cause analysis, and improves decision-making through predictive insights and trend identification. Operating within a hyper-growth context, this role demands P80–P90 talent capable of balancing strategic thinking with rigorous execution and continuous learning agility. The position partners cross-functionally to drive proactive quality improvements, strengthen compliance posture, and scale quality systems to meet increasing production demands while maintaining uncompromising standards. 

Responsibilities:

Quality Execution 

• Analytical Testing: Executes advanced analytical testing of raw materials, in-process samples, and finished products using technologies such as HPLC, FTIR, and endotoxin systems, integrating AI-assisted analytics to enhance accuracy, reduce variability, and accelerate release timelines while ensuring strict adherence to regulatory and internal quality standards. 

• Data Integrity: Maintains rigorous data integrity through precise documentation, review, and verification of laboratory results, leveraging AI-enabled validation tools to detect anomalies, ensure audit readiness, and uphold compliance with FDA regulations and USP standards in a high-throughput environment. 

• Release Decisions: Supports batch and material release decisions by synthesizing analytical data, deviation findings, and compliance requirements, utilizing AI-driven insights to improve decision quality, reduce cycle time, and ensure only compliant, high-quality products reach patients. 

Quality Systems And Compliance 

• Deviation Management: Investigates deviations, out-of-specification results, and non-conformances using structured root cause methodologies enhanced by AI pattern recognition, delivering thorough documentation and corrective actions that prevent recurrence and strengthen overall quality system resilience. 

• Regulatory Alignment: Ensures continuous alignment with 21 CFR Part 211, USP <795>, <797>, and <800> standards by applying deep regulatory knowledge and AI-supported compliance monitoring tools to proactively identify gaps and sustain inspection readiness. 

• Audit Support: Contributes to internal audits, inspections, and Material Review Board activities by preparing data, summarizing findings, and using AI tools to streamline audit preparation, improve transparency, and reinforce a culture of accountability and compliance excellence. 

Continuous Improvement And Collaboration 

• Trend Analysis: Performs ongoing data trending and statistical analysis using AI-enabled platforms to identify emerging risks, optimize processes, and proactively mitigate quality issues before they impact production or compliance outcomes. 

• Cross Collaboration: Partners with manufacturing, R&D, and external laboratories to coordinate testing, stability studies, and investigations, using AI-driven collaboration tools to enhance communication, reduce delays, and ensure alignment across functions. 

• Process Enhancement: Drives continuous improvement initiatives by identifying inefficiencies in testing and quality workflows, applying AI-based optimization techniques to increase throughput, reduce errors, and scale quality operations in a rapidly growing organization. 

Knowledge and Skills:

• Strong expertise in analytical instrumentation, including HPLC, FTIR, TOC, and endotoxin testing, combined with the ability to leverage AI tools for data analysis, anomaly detection, and process optimization. 

• Deep understanding of FDA regulations, USP standards, and 503A/503B compounding requirements, with demonstrated capability to apply compliance knowledge in complex, high-growth pharmaceutical environments. 

• Advanced problem-solving and root cause analysis skills, integrating structured methodologies with AI-driven insights to improve accuracy, speed, and effectiveness of quality investigations. 

• Effective collaboration and communication skills, with the ability to translate complex technical data into actionable insights and leverage digital and AI tools to enhance cross-functional alignment. 

Experience and Qualifications:

• Minimum of 3 years' experience in pharmaceutical Quality Assurance, QC or Regulatory (or Compliance) experience required. 

• Bachelor’s degree in chemistry, biology, or a related field preferred. 

• Demonstrates strong organizational and time management skills, proactive problem-solving, attention to detail, and the ability to work independently while analyzing details and making structured decisions. 

• Possesses expertise in compound pharmacy practices, including United States Pharmacopeia <795>, <797>, and <800>, Food and Drug Administration guidance, and 21 Code of Federal Regulations Part 211, with proficiency in writing reports, reviewing technical documents, handling hazardous chemicals, and working in cleanroom environments. 
• Certified Pharmacy Technician preferred.