Job Summary:
This role provides quality assurance support within the Supplier Controls Quality System for a regulated pharmaceutical environment. The specialist will manage supplier change notifications, initiate change control activities, and ensure compliance with quality system requirements. The position requires strong analytical skills, attention to detail, and the ability to manage complex quality situations independently.
Key Responsibilities:
• Monitor global supplier change notification inbox and track incoming changes
• Evaluate change notifications to identify impacted materials and manufacturing sites using enterprise systems
• Initiate and manage change control records to drive change management activities
• Support collection of feedback from manufacturing sites and cross functional stakeholders
• Ensure change activities comply with internal quality systems and regulatory standards
• Collaborate with quality, operations, and documentation teams to resolve complex issues
• Maintain accurate and timely documentation related to supplier change activities
• Support audits, deviations, corrective and preventive actions, and documentation processes as needed
Required Qualifications:
• Bachelor’s degree in Science or Engineering field
• Four or more years of experience in Quality Systems within a regulated pharmaceutical environment
• Hands-on experience with change control, supplier management, deviations, documentation, corrective and preventive actions, and audits
• Experience working with enterprise systems such as SAP and quality tracking systems
• Strong experience managing complex, ambiguous situations and driving timely resolution
• Excellent written and verbal communication skills
• Strong organizational, time management, and problem-solving skills
• Ability to work independently and cross functionally in a fast-paced environment
Preferred Qualifications:
• Master’s degree in a Science or Engineering discipline
• Prior experience with supplier change notification processes
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range:
