Quality Specialist

Hims & Hers•Los Alamitos, CA

2d•Onsite

About The Position

Hims & Hers is seeking a Quality Specialist (Contract – 2–3 Months) to join our Quality Unit in Los Alamitos, CA. This is a short-term, high-impact role designed for a quality professional with a broad skillset who can provide immediate support across Quality Assurance, Quality Control, Document Control, Training, and Validation functions. This position reports to the Quality Assurance Manager and plays a hands-on role both supporting production and within the Quality Management System (QMS). The ideal candidate is comfortable operating in a fast-paced cGMP facility and can independently manage investigations, documentation, compliance activities, and cross-functional coordination while ensuring adherence to cGMP and other applicable regulations.

Requirements

Bachelor’s degree in Chemistry, Biology, Engineering, Quality Management, or related discipline preferred.
2+ years of experience in Quality Assurance, Quality Control, or a regulated pharmaceutical/compounding environment.
Working knowledge of USP <795>, <797>, <800>, ISO 14644, and cGMP regulations (FDA 21 CFR 210/211).
Experience with investigations, batch record review, document control systems, and audit support.
Strong technical writing skills (SOPs, reports, protocols).
Proficiency with Microsoft Office and electronic quality/training systems (e.g., Trackwise, DMS, LMS/Docebo).
Solid analytical skills, including data trending and basic statistical analysis.
Highly organized, detail-oriented, and capable of working independently in a fast-paced environment.

Nice To Haves

Experience in a 503B outsourcing facility strongly preferred.

Responsibilities

Lead and support quality event investigations (Deviations, OOS) and maintain accurate logs and trackers.
Own and manage Change Controls and support Document Change Control (DCC) activities.
Conduct batch record review (including R&D batches), create and maintain batch record folders, and review COAs and supporting documentation.
Prepare summary reports (e.g., stability reports) and provide trending data to QA management.
Follow up on vendor qualifications and support supplier quality activities.
Ensure compliance with USP <795>, <797>, <800>, FDA 21 CFR 210/211, ISO 14644, and applicable cGMP standards.
Support internal and external audit readiness and contract laboratory coordination.
Perform incoming and receiving inspections, including sampling coordination and documentation.
Support Environmental Monitoring (EM) activities, including data entry, trending, and plate reading.
Track and trend test data to ensure products meet defined specifications.
Provide quality support to manufacturing and pharmacy operations.
Assist with SOP development and revisions related to QC activities.
Support scanning, archiving, indexing, and organization of electronic and physical quality records to ensure audit readiness.
Upload revised SOPs and training materials into learning management system (Docebo); archive obsolete documents in accordance with retention requirements.
Support employee training including tracking, follow-up, administration and grading of quizzes, and escalation of competency gaps.
Maintain accurate logs and trackers for quality events, EM data, training records, and controlled documents.
Support the Document Management System (DMS) implementation, including metadata entry, scanning, upload, routing, and archival workflows.
Assist with calibration tracking and scheduling.
Provide documentation support for validation-related Change Controls and SOP updates.
Support eQMS (Trackwise) and other validation testing, as required.