New

Specialist Manufacturing

Spectraforce Technologies
United States, Ohio, New Albany
Apr 02, 2026
Job Title: Specialist Manufacturing - External Supply Quality Location: New Albany, OH Work Arrangement: Fully Onsite Schedule: 8:00 AM - 5:00 PM (Local Hours) Duration: 6 Months (Possibility of Extension) Top 3 Must Have Skill Sets: Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control) Basic knowledge of Veeva or Trackwise Biotech industry experience Secondary packaging and device Responsibilities: Address and close quality records (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 and ensures compliance with regulatory agency requirements. Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management Support client site as the external supply quality record owner main point of contact and collaborates with the site and technical teams to evaluate observed supplier related defects. Basic Qualifications: Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience Day to Day Responsibilities: Quality record ownership and documentation. Schedule and lead follow up meetings with cross functional partners and suppliers. Engage in meaningful assessments on root cause analysis and evaluation of defect materials. Red Flags: No quality record experience No biotech industry experience