Materials Quality Supervisor

Nature and Scope

Responsible for ensuring that raw materials, primary containers and packaging components used in the manufacture of products for American Regent Inc. meet the established standards of quality.

Essential Duties and Responsibilities

• Supervises and coordinates activities of workers engaged in sampling, inspecting and testing of primary drug components (raw materials), primary packaging, applying knowledge of quality assurance standards and procedures.
• Supervise and coordinates activities of workers engaged in supplier notification activities.
• Directs workers in quality assurance inspection and testing, to assure that SOP's and regulatory standards are met.
• Assigns training of new workers to qualified workers.
• Reviews/Approves reports and confers with quality assurance, production, management, and engineering personnel to solve work-related problems.
• Draft/revise quality assurance policies and procedures.
• Interpret and implement quality assurance standards.
• Evaluate adequacy of quality assurance standards.
• Devise sampling procedures and directions for recording and reporting quality data.
• Review the implementation and efficiency of quality and inspection systems.
• Collect and compile statistical quality data.
• Initiate events, perform Root Cause Analysis, Impact Assessments, CAPA's and Effectiveness Checks related to Incoming material and assist other departments with Investigations as required.
• Manage the Destruction Approval (DAF) of material process which includes assigning DAF numbers and disposition of material to be disposed of.
• Facilitate and evaluate audit findings, implement appropriate corrective actions.
• Drives QUALITY culture and Core Competency Model initiatives in support of enhanced organizational performance.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• Bachelor's degree or equivalent work experience.
• Minimum 5 or more years' experience in industry.
• Quality inspection, auditing and testing experience.
• Experience with investigation writing and implementation of corrective action programs.
• Product or industry-specific experience.
• 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.

Physical Environment and Requirements

• Must have 20/20 vision, corrected if necessary.
• Must successfully pass Color Blindness Screening (D15).