Manufacturing Specialist

Payrate: $40.00 - $41.00/hr.

The role involves managing and executing processes related to quality records, ensuring compliance with regulatory requirements, and providing timely updates to senior management.

• Address and close quality records such as Deviations, Corrective and Preventive Actions (CAPAs), CAPA‑Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR/EN), and Change Control under the company's quality management system procedures.
• Mentor and lead peers in functional areas and Quality Operations in implementing investigations of varying complexity.
• Facilitate cross‑functional teams (internal and external) to achieve robust and detailed investigation performance.
• Monitor and investigate deviations owned by External Supply and implement corrective/preventive actions.
• Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions using advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner‑Tregoe, etc.).
• Manage closure of multiple quality records simultaneously and in a timely manner.
• Collaborate with suppliers and External Supply peers to address and close critical investigations and Corrective Actions.
• Build and present quality records summaries for Senior Management review and provide timely updates.
• Communicate Quality records status to Senior Leadership in multiple forums and maintain metric reporting for performance.

• Doctorate degree OR Masters degree with 2 years of experience OR Bachelors degree with 4 years of experience OR Associates degree with 8 years of experience OR High school diploma / GED with 10 years of experience.
• Experience with Veeva, Track Wise, Smartsheet, and MS Office.

• Project Management skills.
• Quality Management skills and experience.
• Experience as a Quality Record Owner.

The typical base pay for this role across the U.S. is $40.00 - $41.00/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. 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 are provided based on state or local law.