Quality Systems Specialist

Hims & Hers • Gilbert, AZ

2d

About The Position

We are seeking a Quality Systems Specialist to join our Quality Unit in XeCare Pharmacy. This position plays a critical role in ensuring that all compounded products meet company and regulatory standards before release. The role has a heavy emphasis on documentation surrounding batch issuance, review, filing, and escalation of events, and will support the QS Manager in daily operations. The QS Specialist is responsible for ensuring compliance with USP standards, Good Documentation Practices (GDP) requirements, and internal SOPs while safeguarding patient safety.

Requirements

• Bachelor’s degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience.
• 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
• Strong understanding of USP <795>, <797>, <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP, GDP and GLP practices preferred.
• Excellent attention to detail, documentation practices, and organizational skills.
• Experience with investigations, deviation management, and escalation procedures.
• Proficiency in Google Workspace and familiarity with quality systems software.
• Strong interpersonal and communication skills (written and verbal).

Responsibilities

• Manage batch record issuance of compounded lots.
• Perform detailed review of executed batch records, associated records and test results to ensure accuracy, completeness, and compliance with USP <795>, USP <797>, USP <800> and internal procedures. This practice will also include the scanning, filing, and archiving of site documents in both digital and physical systems.
• Audit documentation for compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available)
• Support the design and enhancement of quality system tools and workflows, ensuring alignment with regulatory requirements and business needs..
• Ensure timely filing and archival of batch-related documentation to support audit readiness.
• Participate in the escalation, investigation, and closure of deviations, OOS (out-of-specification) results, and discrepancies, ensuring timely investigation and resolution.
• Collaborate with Compounding, Pharmacy, Quality Control, and Inventory teams to ensure consistent batch activities have been documented and completed .
• Provide reports, trending data, and metrics to QS management to identify patterns and continuous improvement opportunities.
• Support internal and external audits by providing documentation and evidence related to raw material and component discrepancies and lot disposition.
• Participate in drafting and revising SOPs, work instructions, and protocols relating to quality system activities.
• Label Issuance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees