Supervisor, Quality Operations

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Supervisor, Quality Operations, is responsible for overseeing daily quality operations in compliance with cGMP regulations, company policies, and industry standards. This role ensures the effective execution of quality-related activities, including batch record issuance, quality presence on the floor, batch record review, and product/lot release.

Essential Duties And Role Responsibilities

This role must maintain a strong working relationship cross-functionally with Operations while maintaining cGMP compliance. This position reports to the Manager, Quality Operations.

Job Responsibilities

• Supervise and coordinate daily activities of the Quality Operations team consisting of Quality Assurance Analysts which includes but is not limited to:
• Oversee batch record review and approval processes to ensure compliance with cGMPs, GDP, SOPs, and regulatory requirements.
• Ensure timely product disposition and release in coordination with manufacturing and supply chain teams.
• 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 as appropriate
• Carefully reviews raw material paperwork to ensure rest and expiration dates are correct
• Assign 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 and MasterControl as appropriate
• Attends quality management and product planning/scheduling meetings
• Participate/Support continuous improvement initiatives related to quality systems and manufacturing processes
• Ensure compliance with company safety, quality, and regulatory policies.
  
  

Required Skills And Experience

• High school level of education
• 7+ 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
• Proficiency in cGMP, GDP and quality systems
  
  

California residents should review our Notice for California Employees and Applicants before applying.

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Apply Now