Quality Systems Lot Disposition Specialist

About the Role :

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.

You Will :

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. 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 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.

GDP Additions

Label Issuance

You Have :

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).

Pharmacy Technician or trainee license or willingness to acquire.

Our Benefits (there are more but here are some highlights) :

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

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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