Assistant Manager-Validation & QMS

Tailstorm Health Inc•Chandler, AZ

19d•Onsite

About The Position

The Assistant Manager – Validation & QMS supports Medivant’s sterile injectable manufacturing operations by coordinating validation activities, quality system processes, and compliance initiatives. This role ensures all validation work meets cGMP, FDA requirements, and internal SOPs.

Requirements

Bachelor’s or Master’s in Pharmacy, Biotechnology, Microbiology, or related field.
2–5 years of validation/QMS or sterile manufacturing experience.
Knowledge of cGMP, FDA regulations, and aseptic practices.
Strong analytical, documentation, and communication skills.

Nice To Haves

Experience in sterile injectable or aseptic manufacturing.
Familiarity with QMS tools, validation software, or ERP systems.

Responsibilities

Execute and support media fill studies; review results and recommend corrective actions.
Lead area qualifications for classified areas (Grade A–D) and support environmental monitoring.
Prepare and execute IQ/OQ/PQ protocols and review qualification documentation.
Coordinate utility validation (HVAC, WFI, compressed air).
Develop and review cleaning validation procedures and reports.
Lead process validation protocol creation, execution, and reporting.
Initiate and review change controls and assess impacts.
Perform deviation investigations and root-cause analysis.
Lead CAPA implementation and verify timely closure.
Support OOS/OOT investigations and regulatory documentation.
Assist during internal/external audits.