Materials Quality Lead: Raw Materials & Packaging

American Regent, Inc.; New Albany (OH); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

American Regent Inc. seeks a Materials Quality Supervisor to lead QA activities for raw materials and primary packaging at New Albany, OH. You will supervise testing, auditing, and supplier notifications, ensuring compliance with SOPs and regulatory standards.

You will draft QA policies, perform root cause analyses, manage CAPAs, and drive a culture of quality. The role requires a bachelor’s degree, 5+ years in industry, and strong communication and organizational skills.

Qualifications

• Bachelor’s degree or equivalent work experience.
• Minimum 5+ years’ experience in industry.
• Quality inspection, auditing and testing experience.
• Experience with investigation writing and implementation of corrective action programs.
• Knowledge of relevant regulatory requirements.
• Proficient in MS Word, Excel and Outlook.
• Strong oral and written communication skills.
• Strong time management and organizational skills, able to delegate tasks as needed.

Responsabilités

• Supervises and coordinates activities of workers engaged in sampling, inspecting and testing of primary drug components (raw materials) and primary packaging.
• Directs workers in supplier notification activities and in QA inspection and testing to meet SOPs and regulatory standards.
• Draft/revise quality assurance policies and procedures; interpret and implement QA standards.
• Review/approve reports and confer with QA, production, management and engineering to solve problems.
• Initiate events, perform Root Cause Analysis, CAPA and Effectiveness Checks related to incoming material.
• Manage Destruction Approval (DAF) of material and disposition of material to be disposed of.
• Facilitate and evaluate audit findings and implement corrective actions.
• Drive QUALITY culture and Core Competency Model initiatives.

Connaissances

Quality inspection

Auditing

Testing

Investigation writing

CAPA

Regulatory knowledge

Communication skills

Time management

Formation

Bachelor’s degree or equivalent

Outils

MS Word

Excel

Outlook

Description du poste

American Regent Inc. seeks a Materials Quality Supervisor to lead QA activities for raw materials and primary packaging at New Albany, OH. You will supervise testing, auditing, and supplier notifications, ensuring compliance with SOPs and regulatory standards.

You will draft QA policies, perform root cause analyses, manage CAPAs, and drive a culture of quality. The role requires a bachelor’s degree, 5+ years in industry, and strong communication and organizational skills.