Quality Systems SOP & Change Control Specialist

Hims & Hers; Mesa (AZ); Sur place; USD 85 000 - 110 000; Plein temps

Avantages offerts par ce poste

Comprehensive health benefits

401k with employer matching

Résumé du poste

Hims & Hers seeks a Quality Systems Document Control Specialist to join the XeCare Pharmacy Quality Unit. This role supports the document control system and lifecycle of controlled documents within a 503A compounding pharmacy, with emphasis on Change Control, SOP development, and compliance tracking.

You will manage SOPs, batch records, forms, and policies, ensuring current versions are in circulation and aligning with USP <795>, <797>, <800>, and FDA 21 CFR 210/211.

Qualifications

• 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.

Responsabilités

• 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 change controls and assess impact to site documentation and processes.
• Assist in drafting, editing, and formatting SOPs, work instructions, and policies per regulatory requirements.
• Manage SOP lifecycle including periodic reviews, approvals, revisions, and retirement of obsolete versions.
• Coordinate cross-functional SME reviews with QA, Production, QC, and Compliance.
• Ensure timely training rollout when new/revised SOPs are released and maintain training records.
• Maintain both electronic and physical filing systems for easy retrieval and audit readiness.
• Monitor document-related deviations and escalate to QA Management for corrective action.
• Prepare documentation packages for regulatory inspections and customer audits.
• Collaborate with QS Management on continuous improvement of the document control process.

Connaissances

SOP drafting

Editing

Attention to detail

Cross-functional collaboration

Formation

Bachelor’s degree preferred

Outils

EDMS

Description du poste

Hims & Hers seeks a Quality Systems Document Control Specialist to join the XeCare Pharmacy Quality Unit. This role supports the document control system and lifecycle of controlled documents within a 503A compounding pharmacy, with emphasis on Change Control, SOP development, and compliance tracking.

You will manage SOPs, batch records, forms, and policies, ensuring current versions are in circulation and aligning with USP <795>, <797>, <800>, and FDA 21 CFR 210/211.