Onsite QA Manager Sterile Injectables & Compliance

Medivant Healthcare; Chandler (AZ); Presencial; USD 120.000 - 150.000; Jornada completa

Descripción de la vacante

Medivant Healthcare, a manufacturer of sterile injectable medications, seeks a Manager QA– MQA to oversee documentation control, batch record review, sampling, and material releases. The role ensures cGMP compliance and supports daily quality operations across production and packaging.

The position is full-time and onsite, with responsibilities spanning line clearances, MBMR/BMR preparation, investigations, and labeling reviews. Strong QA background and MasterControl experience preferred.

Formación

• Bachelor’s degree in a scientific discipline as listed.
• 7–10 years in pharma QA or manufacturing QA roles.
• Knowledge of cGMP, documentation practices, sampling procedures, and material release processes.
• Strong attention to detail and organizational skills.

Responsabilidades

• Upload documents into the Document Management System (DMS).
• File and archive documents with tracking records for retrieval and archival.
• Review and release incoming materials per Approved Vendor List and CoA requirements.
• Issue controlled documents and logbooks to all departments.
• Perform AQL inspections as required.
• Conduct line clearances and in-process/finished-product sampling for manufacturing and packaging.
• Prepare Master Batch Manufacturing Records (MBMRs) and review Batch Manufacturing Records (BMRs).
• Pull, label, and store product samples after manufacturing.
• Support product and material destruction processes.
• Participate in failure investigations and support documentation.
• Review label printing for accuracy and compliance.

Conocimientos

Attention to detail

Documentation practices

Quality assurance

Regulatory compliance

Educación

Bachelor’s degree in Pharmacy, Biotechnology, Chemistry, or related scientific discipline

Herramientas

MasterControl

Electronic documentation systems

Descripción del empleo

Medivant Healthcare, a manufacturer of sterile injectable medications, seeks a Manager QA– MQA to oversee documentation control, batch record review, sampling, and material releases. The role ensures cGMP compliance and supports daily quality operations across production and packaging.

The position is full-time and onsite, with responsibilities spanning line clearances, MBMR/BMR preparation, investigations, and labeling reviews. Strong QA background and MasterControl experience preferred.