Quality Systems & SOP Control Specialist

Hims & Hers; Gilbert (AZ); Presencial; USD 75 000 - 105 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health benefits

401k matching

Resumo da oferta

Hims & Hers is seeking a Quality Systems Document Control Specialist to join our XeCare Pharmacy Quality Unit in Gilbert, AZ. This role focuses on supporting the document control system and lifecycle of controlled documents, with emphasis on change control, SOP development, controlled issuance, review, filing, archival, and compliance tracking.

You will manage SOPs, batch records, and forms, ensure current versions are in circulation, collaborate with QA, Production, and Compliance, and help

Qualificações

• 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.
• Hands‑on experience with SOP drafting, formatting, and controlled documentation systems.
• In‑depth knowledge of cGMP documentation practices, USP standards, and FDA record‑keeping requirements.
• Exceptional attention to detail with strong editing, writing, and organizational skills.
• Familiarity with electronic document management systems (EDMS) or validated document control or quality management software.
• Strong collaboration skills, with the ability to work across QA, Production, and Compliance teams.

Responsabilidades

• Support the administration of the Document Control System, ensuring proper management of controlled documents such as SOPs, batch records, logbooks, forms, policies, and protocols.
• Support the site level implementation of change controls and the impact to site documentation and defined processes.
• Support the design and enhancement of quality system tools and workflows, ensuring alignment with regulatory requirements and business needs.
• Issue and track SOPs and other controlled documents, ensuring only current, approved versions are in circulation.
• Assist in drafting, editing, and formatting SOPs, work instructions, and policies, ensuring clarity, consistency, and alignment with USP <795>, <797>, <800>, and FDA 21 CFR 210/211.
• Support SOP lifecycle management, including periodic review, approval workflows, revision history tracking, and retirement of obsolete versions.
• Support cross-functional SME reviews of SOPs and controlled documents, ensuring input from QA, Production, QC, and Compliance.
• Ensure timely training roll-out when new or revised SOPs are released, and maintain records to demonstrate compliance in alignment with the Training department and Operations teams.
• Maintain both electronic and physical filing systems, ensuring secure storage, easy retrieval, and audit readiness.
• Monitor document-related deviations, including missing signatures, uncontrolled copies, or outdated references, and elevate to QA Management for corrective action.
• Prepare and provide documentation packages for regulatory inspections and customer audits.
• Partner with QS Management to support continuous improvement of the document control process, including digitization initiatives and standardization projects.

Conhecimentos

SOP drafting

EDMS experience

cGMP documentation

Technical editing

Cross-functional collaboration

Formação académica

Bachelor’s degree or equivalent

Ferramentas

EDMS software

QA/QC systems

Descrição da oferta de emprego

Hims & Hers is seeking a Quality Systems Document Control Specialist to join our XeCare Pharmacy Quality Unit in Gilbert, AZ. This role focuses on supporting the document control system and lifecycle of controlled documents, with emphasis on change control, SOP development, controlled issuance, review, filing, archival, and compliance tracking.

You will manage SOPs, batch records, and forms, ensure current versions are in circulation, collaborate with QA, Production, and Compliance, and help