Specialist Manufacturing

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

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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $38.83/hr.