Materials Quality Supervisor

American Regent, Inc.•New Albany, OH

16h

About The Position

The Materials Quality Supervisor is responsible for ensuring that raw materials, primary containers, and packaging components used to manufacture American Regent Inc. products meet established quality standards. This role supervises employees engaged in sampling, inspecting, and testing incoming materials and primary packaging, as well as supplier notification activities. The supervisor ensures quality assurance work meets SOPs and regulatory standards, develops and implements quality procedures, and works with quality assurance, production, management, and engineering personnel to address work-related problems. The role also manages quality events and investigations related to incoming materials, including root cause analyses, impact assessments, corrective and preventive actions, and effectiveness checks. It oversees the destruction approval process for materials designated for disposal and facilitates audit findings and corrective actions. The position supports quality culture and organizational performance initiatives and may perform other duties assigned by management.

Requirements

Bachelor’s degree or equivalent work experience.
At least 5 years of industry experience.
Experience in quality inspection, auditing, and testing.
Experience writing investigations and implementing corrective action programs.
Product- or industry-specific experience.
Knowledge of relevant regulatory requirements.
Proficiency in MS Word, Excel, and Outlook.
Strong oral and written communication skills.
Strong time management and organizational skills, with the ability to delegate tasks as needed.
Must have 20/20 vision, corrected if necessary.
Must successfully pass Color Blindness Screening (D15).

Responsibilities

Supervise and coordinate employees engaged in sampling, inspecting, and testing raw materials and primary packaging components.
Supervise and coordinate supplier notification activities.
Direct quality assurance inspection and testing to ensure SOPs and regulatory standards are met.
Assign training of new workers to qualified employees.
Review and approve reports, and confer with quality assurance, production, management, and engineering personnel to resolve work-related problems.
Draft and revise quality assurance policies and procedures.
Interpret and implement quality assurance standards, and evaluate their adequacy.
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 and perform root cause analyses, impact assessments, CAPAs, and effectiveness checks related to incoming materials; assist other departments with investigations as required.
Manage the Destruction Approval (DAF) process, including assigning DAF numbers and determining disposition of material to be disposed of.
Facilitate and evaluate audit findings and implement appropriate corrective actions.
Drive quality culture and Core Competency Model initiatives in support of enhanced organizational performance.
Perform other tasks and duties assigned by management.