Quality Control Specialist 503B

Position Summary

Quality Control Specialist 503B protects product quality, compliance, and manufacturing continuity across Empower’s 503A and 503B operations through inspection, sampling, testing coordination, and documentation. This role ensures accurate execution, deviation identification, and data integrity supporting patient safety and operational reliability. Leveraging AI-enabled quality systems, analytics, and automation, the position improves review speed, inspection accuracy, and decision-making. Success requires execution rigor, learning agility, and disciplined problem solving within a highly regulated, fast-paced environment.

Responsibilities

• Quality Operations Inspection Execution: Performs material inspections, sampling, and quality verification supporting compliant manufacturing and product release. Utilizes AI-enabled systems and workflows to improve inspection accuracy, processing speed, and documentation quality while supporting reliable decision-making.

• Testing Coordination: Coordinates sample management, testing activities, and laboratory communication supporting product quality and operational continuity. Leverages AI-assisted analytics and digital systems to improve visibility, reduce delays, and strengthen compliance execution.

• Deviation Support: Draft Nonconformance investigations and assist in investigations, impact assessments, deviation tracking, and CAPA and change control activities supporting compliance and audit readiness. Applies AI-powered analytics to identify trends, improve responsiveness, and strengthen root cause visibility.

• Compliance And Documentation Record Accuracy: Maintains accurate, audit-ready records supporting cGMP compliance and manufacturing continuity. Uses digital systems and AI-assisted tools to improve data integrity, reduce errors, and strengthen process consistency.

• Regulatory Alignment: Executes quality activities aligned with FDA, USP, and company procedures supporting safe manufacturing operations. Leverages AI-enabled compliance tools to improve visibility and decision-making.

• Audit Readiness: Supports audits and inspections through organized documentation and adherence to procedures. Uses AI-powered reporting tools to improve preparedness and compliance responsiveness.

• Continuous Improvement Process Enhancement: Identifies opportunities to improve workflows, documentation, and inspection processes. Uses AI-driven analytics and automation to improve efficiency, compliance, and operational performance.

• Cross functional Partnership: Collaborates with Manufacturing, QA, Warehouse, and Laboratory teams to resolve issues and support operations. Leverages digital tools to improve communication and execution.

• Knowledge Development: Expands expertise in quality systems and regulatory standards while leveraging AI tools to improve performance and adaptability in a fast-paced environment.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Quality, Pharmaceutical Sciences, Operations, or related discipline preferred.

• Minimum 2 years of quality control, manufacturing, laboratory, or regulated operational experience supporting pharmaceutical, healthcare, biotechnology, or similarly regulated industries preferred.

• Experience supporting inspections, quality documentation, deviation management, audit readiness, and electronic quality systems strongly preferred.

• Familiarity with FDA regulations, cGMP standards, USP requirements, AI-enabled quality technologies, and digital workflow platforms preferred.

• Demonstrated ability to execute with precision, adapt rapidly to changing operational demands, and contribute effectively within collaborative, high-performance teams.