Product and Labeling Inspector 503A (2nd shift)

Position Summary

The Product and Labeling Inspector ensures product integrity, labeling accuracy, and regulatory compliance across Empower's 503A and 503B operations. This role owns inspection execution, deviation identification, and release readiness within a high-throughput, quality-critical environment. The inspector leverages AI-enabled tools to detect anomalies, streamline documentation, and enhance inspection consistency.

Operating at P80-P90 performance expectations, this individual delivers precision, speed, and accountability, directly impacting patient safety, audit readiness, and operational excellence across manufacturing, packaging, and distribution workflows.

Responsibilities

Inspection Execution

• Visual Verification: Perform detailed inspections of products and labels to ensure accuracy, compliance, and defect-free release. Leverage AI-assisted detection tools to enhance inspection consistency and identify potential anomalies.
• Batch Review: Validate batch records for completeness, traceability, and alignment with cGMP requirements. Utilize AI-supported document analysis tools to improve review accuracy, efficiency, and documentation quality.
• Sampling Control: Execute sampling procedures to ensure representative selection, sample integrity, and compliance with established quality standards. Maintain accurate records using approved digital tracking systems.

Compliance Assurance

• Regulatory Alignment: Perform inspection activities in accordance with applicable 503A and 503B requirements, established procedures, and quality standards. Use AI-enabled tools to support identification and monitoring of compliance trends and potential deviations.
• Deviation Identification: Identify, document, and escalate discrepancies involving products, labels, or inspection results. Leverage AI-enabled anomaly detection and reporting tools to improve issue identification, documentation, and timely escalation.
• Audit Support: Maintain accurate, inspection-ready records and prepare relevant inspection data and documentation to support internal and external audits.

Process Improvement

• Continuous Improvement: Identify inspection inefficiencies and recommend improvements that enhance quality, speed, and consistency. Use AI-generated insights and operational data to support continuous improvement initiatives.
• Data Utilization: Analyze inspection data and trends using AI-enabled tools to identify recurring issues, support proactive quality improvements, and strengthen operational decision-making.
• Standard Adherence: Maintain strict adherence to standard operating procedures (SOPs) and established quality requirements while contributing operational feedback and inspection insights that support continuous improvement of procedures and processes.

Knowledge and Skills

• Strong understanding of cGMP requirements, 503A/503B operations, and quality systems within pharmaceutical manufacturing or similarly regulated environments.
• Ability to leverage AI-enabled and digital tools to support inspection accuracy, data analysis, documentation, and continuous improvement initiatives.
• High attention to detail with strong analytical and systems-thinking capabilities in regulated production environments.
• Effective communication and documentation skills with the ability to maintain clarity, compliance, and cross-functional alignment in a fast-paced environment.

Experience and Qualifications

• Minimum of two (2) years of experience in pharmaceutical manufacturing, quality inspection, or another regulated production environment.
• Demonstrated experience identifying defects, maintaining compliance, and supporting audit readiness within high-throughput operations.
• Experience working within 503A or 503B operations or similarly regulated pharmaceutical or healthcare manufacturing environments preferred.
• Demonstrated ability to use digital or AI-enabled tools to enhance inspection accuracy, reporting efficiency, and quality outcomes.

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.

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.

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.