Quality Operations Specialist 503B (1st shift)

The Quality Operations Specialist ensures consistent delivery of safe, sterile, and compliant pharmaceutical products, directly impacting patient outcomes and regulatory standing. This role owns end-to-end quality oversight across manufacturing review, deviation management, and compliance assurance within a fast-scaling 503A/503B environment. Leveraging AI as a force multiplier, the Specialist enhances review speed, improves deviation detection, strengthens root cause analysis, and enables data-driven decision-making at scale. Operating with high autonomy, this role integrates quality into operational execution while continuously improving systems and processes. Success requires P80–P90 talent marked by sharp strategic thinking, disciplined execution, and strong learning agility, enabling rapid adaptation to evolving regulatory expectations and supporting Empower’s trajectory as a hyper-growth, quality-first pharmaceutical leader in a complex, highly regulated industry landscape.

Quality Execution

• Batch Review: Conduct detailed review of cGMP batch records and manufacturing documentation, leveraging AI-enabled validation tools to identify discrepancies, improve review accuracy, and accelerate throughput while ensuring full compliance with regulatory requirements and internal quality standards across sterile and non-sterile operations.

• Process Monitoring: Monitor manufacturing activities to ensure adherence to aseptic techniques, cleanroom standards, and operational procedures, utilizing AI-supported systems to detect deviations in real time, enabling rapid response and sustained control over product sterility, safety, and consistency.

• Release Support: Support product release readiness by verifying data integrity and completeness, applying AI-driven insights to strengthen decision-making, reduce release cycle times, and ensure alignment with regulatory expectations and organizational quality benchmarks.

Deviation And Investigation

• Deviation Handling: Identify, document, and support triage of deviations, using AI tools to detect trends, classify issues, and prioritize risks while ensuring timely escalation and compliance with internal procedures and regulatory reporting standards.

• Root Analysis: Perform structured root cause analysis using data-driven methodologies and AI-assisted pattern recognition to uncover underlying issues, enabling targeted corrective actions that enhance process reliability and prevent recurrence.

• CAPA Support: Assist in the development and implementation of corrective and preventive actions, leveraging AI-enabled tracking and analytics to monitor effectiveness, ensure closure, and drive continuous improvement across quality systems.

Compliance And Efficiency

• Regulatory Adherence: Execute quality processes in alignment with FDA and state regulations within a 503A/503B environment, utilizing AI tools to maintain documentation accuracy, enhance audit readiness, and proactively identify compliance gaps.

• Environmental Monitoring: Perform and support environmental monitoring activities, applying AI-driven trend analysis to detect shifts in cleanroom conditions and ensure ongoing compliance with sterility and contamination control standards.

• Operational Support: Collaborate with cross-functional teams to resolve quality issues and improve workflows, using AI-enabled collaboration and data-sharing tools to enhance efficiency, ensure consistency, and support high-quality operational execution.

• Strong knowledge of cGMP regulations, sterile and non-sterile manufacturing processes, and quality systems, with the ability to apply AI tools to enhance compliance, documentation accuracy, and operational decision-making.

• Proficiency in data analysis, root cause investigation methodologies, and CAPA processes, complemented by experience using AI-driven analytics to identify trends, risks, and performance improvement opportunities.

• Advanced organizational, prioritization, and multitasking capabilities, with the ability to manage complex workflows in fast-paced, highly regulated environments while maintaining precision and accountability.

• Effective communication and cross-functional collaboration skills, with experience leveraging digital and AI-enabled tools to drive alignment, streamline workflows, and support high-quality execution.

Key Competencies

• Customer Focus: Builds trust through customer-centric solutions 

• Strategic AI: Guides responsible AI adoption and adaptation 

• Optimizes Work Processes: Drives efficiency with continuous improvement 

• Collaborates: Partners effectively to achieve shared goals 

• Resourcefulness: Secures and deploys resources efficiently 

• Manages Complexity: Simplifies and solves complex challenges 

• Ensures Accountability: Delivers on commitments with integrity 

• Situational Adaptability: Adjusts approach to shifting conditions 

• Communicates Effectively: Tailors messages to diverse audiences 

Values

• People: Empowering people defines who we are 

• Quality: Excellence in every product, every time 

• Service: Serving others is our highest purpose 

• Innovation: Advancing care through technology and discovery

• Minimum of 4 years of directly related experience.

• Bachelor of Science in a science-related discipline.

• Strong attention to detail, organizational, and prioritization skills, with the ability to multitask effectively while adhering to aseptic and regulatory standards.

• Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook) with required experience in sterile and nonsterile manufacturing and knowledge of state and federal regulations.

Employee Benefits, Health, and Wellness:

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. 

Learn more: https://careers.empowerpharmacy.com/benefits/ 

Physical Requirements

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.