Quality Assurance Analyst

 

Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturing (CDMO) business. This position is for a Quality Assurance Analyst for our Northridge operations. Our Northridge site manufactures and packages pharmaceutical products.

Kindeva is navigating a period of dynamic change and growth because of business opportunities in its pipeline and ongoing commercial product manufacture. It partners with global pharmaceutical companies to commercialize products, primarily through inhalation and transdermal delivery technologies. We are looking for a talented Quality Assurance Analyst to join our Northridge team.

Summary of Position

To review completed batch manufacturing orders for the Northridge Quality Assurance function before the release of finished product. To ensure compliance with appropriate internal procedures and regulatory expectations.

Key Working Relationships:
This role must maintain strong working relationships cross-functionally with employees, and external partners across the global enterprise. This position reports to the Site Quality Manager.

Job Responsibilities

• Reviews completed batch manufacturing orders and analytical reports for accuracy, completeness, and compliance
• Reviews raw materials and semi-finished goods for use in production
• Dispositions (release/reject) materials and products in Microsoft D365 and StarLims
• Carefully reviews raw material paperwork to ensure rest and expiration dates are correct
• Assigns expiration dates on manufacturing documents and in the inventory management system
• Processes transactions in the inventory management system (D365) for material or item status changes per Material Status Disposition process
• Uploads manufacturing and quality documentation to Sharepoint sites for customer review
• Prepares and issues Manufacturing Orders to production
• Support and participate in internal/external audits
• Files Batch Records and other critical documents in the Documentation Center
• Attends quality management and product planning/scheduling meetings
• Support continuous improvement activities within the Quality Department and the Northridge facility.

Required Skills and Experience

• High school level of education
• Between 2 and 3 years of related job experience
• Proficient computer skills (MS Word, Excel)
• Good organizational skills
• Good communication skills (verbal, written)
• Good time management skills
• Ability to work independently, self-motivated, and flexible
• Works well in a team environment

Preferred Skill and Experience

• Knowledge of basic cGMPs and quality systems

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