Vantive · 5 hours ago
Quality Associate II
Deerfield, IL
Full-time
Hybrid
Mid Level
$80K/yr - $90K/yr
3+ years expVantive is a vital organ therapy company focused on enhancing the dialysis experience through innovative digital solutions. The Quality Associate II will ensure compliance with regulatory and quality standards for warehousing and distribution operations in the US and Canada, managing quality oversight and partnerships with external suppliers.
Health CareMedicalTherapeuticsWellness
Responsibilities
Responsible to ensure compliance with Regulatory, Corporate and Local Quality requirements and for providing Quality oversight of Vantive US and Canada warehousing and distribution operations, including internal warehouse site QA activities, internal renal fleet drivers, external warehousing partners (i.e., 3PL providers, wholesalers, freight forwarders and consolidation/ deconsolidation centers), and external transportation providers
Oversight of distribution/warehouse-related external suppliers
Act as a key partner with US and Canada Vantive Operations (including Supply Chain, Logistics and Fulfillment) to manage Quality requirements and oversight of all 3PL activities
Responsible for compliance with FDA and Health Canada requirements, ISO standards and Vantive QMSby applying rigorous quality standards, including Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Responsible for the implementation of Distribution QA activities to ensure compliance to FDA and Health Canada requirements. This includes activities related to issue management (product dispositions, deviations, complaint investigations, holds), site QA management (pest control, temperature monitoring, returns, validation) and internal/supplier/3PL QA management (warehouses, internal private fleet, transportation carriers, suppliers impacting fulfillment)
Participate in discussions and on projects and cross-functional teams as required
Support distribution and warehousing-associated external suppliers which includes audit support, supplier corrective action requests, quality/distribution agreements, new supplier requests, supplier notifications of change and change controls
Work closely with UCAN planning and fulfillment organizations to meet business goals and objectives
Facilitate and assist in GMP, ISO, US state distribution/pharmacy licensing and other internal/external audits and investigations pertaining to Vantive and/or 3PL facilities, where applicable
Qualification
Required
Bachelor's Degree required (preferably in science, engineering or equivalent field)
Minimum of 3 years of experience in Quality, or related field in the medical products/pharmaceutical industry
Able to manage multiple projects and/or responsibilities simultaneously
Support in meeting and exceeding quality key performance indicators (KPIs)
Solid understanding of FDA Regulations, Health Canada requirements and Application of Good Distribution Practices
Must be proficient with Microsoft Office and other data collection/analysis programs (e.g. Minitab)
Excellent interpersonal/communication/presentation/negotiation skills
Must have basic English written and oral communication skills adequate to connect with other team members
Initiative to be a subject matter expert in select processes and areas
Supports ethical behaviors and decision-making
Preferred
Experience preferred for the following: distribution and warehousing in US and Canada, Quality Management Systems, FDA and Health Canada regulations, supplier quality
Benefits
Medical, dental and vision coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
401(k) retirement savings plan
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
The Employee Discount Program
The Employee Assistance Program (EAP)
Childcare benefits
Company
Vantive
Vantive US Healthcare LLC specializes in kidney care and organ support therapies with digital solutions.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-08-13Acquired
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