Quality Systems Lot Disposition Specialist

Hims & Hers-posted 3 months ago
Full-time • Mid Level
New Albany, OH
11-50 employees
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We are seeking a Quality Systems Lot Disposition 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 Lot Disposition Specialist is responsible for ensuring compliance with USP standards, cGMP requirements, and internal SOPs while safeguarding patient safety.

  • Manage batch record issuance, review, and final disposition of compounded lots.
  • Perform detailed review of executed batch records to ensure accuracy, completeness, and compliance with cGMP and internal procedures.
  • 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.
  • Collaborate with Production, Pharmacy, QC, and Inventory teams to ensure smooth lot disposition activities.
  • 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 lot disposition.
  • Participate in drafting and revising SOPs, work instructions, and protocols relating to lot disposition.
  • 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.
  • 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).
  • Pharmacy Technician or trainee license or willingness to acquire.
  • GDP and GLP practices preferred.
  • Competitive salary & equity compensation for full-time roles.
  • Unlimited PTO, company holidays, and quarterly mental health days.
  • Comprehensive health benefits including medical, dental & vision, and parental leave.
  • Employee Stock Purchase Program (ESPP).
  • 401k benefits with employer matching contribution.
  • Offsite team retreats.
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