Manufacturing Specialist

Payrate: $42.00 - $44.00/hr.
 
Summary:
The role involves owning and executing all processes related to deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records under minor supervision. The individual will act as the External Supply representative across functional teams to ensure timely closure of quality records. This position requires managing quality records originating from manufacturing sites across the network.
 
Responsibilities

• Address and close quality records (Deviations, CAPAs, CAPA-EV, Supplier Event Notifications and Investigations, and Change Control) in accordance with the company's quality management system procedures and regulatory requirements.
• Facilitate cross-functional teams to achieve robust and detailed investigation performance.
• Manage the closure of multiple quality records simultaneously and efficiently.
• Collaborate with suppliers and External Supply peers to resolve critical investigations and corrective actions.
• Build and present quality records summaries for senior management review, providing timely and comprehensive updates on process and status.
• Communicate quality records status to senior leadership across various forums and maintain performance metric reporting.

 
Qualifications

• Experience managing quality records (Deviations, CAPAs, CAPA-EV, Change Controls, SCARs) using TrackWise and/or Veeva System.
• Proficiency in navigating and executing transactions in the SAP (ERP) system.
• Project Management and/or Quality Management skills with demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.

 
Skills

• Strong communication skills for presenting information to senior management and leadership.
• Ability to manage multiple tasks and projects simultaneously with attention to detail.
• Experience in working collaboratively with cross-functional teams.

 
Pay Transparency: The typical base pay for this role across the U.S. is: $42.00 - $44.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
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