Material Quality Specialist

American Regent•Shirley, NY

7d•Onsite

About The Position

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.

Requirements

Bachelor’s degree or 8 years of equivalent work experience, required.
5-7+ years’ experience in Quality inspection, auditing, or testing within the pharmaceutical industry is required.
Experience with investigation writing and implementation of corrective action programs.
Proficiency in Microsoft Office, specifically Word and Excel, for creating reports and maintaining spreadsheets.
Strong written and verbal communication skills.
Ability to multi-task and work independently with minimal supervision.
Must have 20/20 vision, corrected if necessary.
Must successfully pass Color Blindness Screening (D15).

Responsibilities

Creates monthly reports such as Annual Product Review (APR) and metric documents for the Material Quality Management department.
Assist in drafting and/or revising Quality policies and procedures.
Assist Material Quality Management in interpreting and implementing quality assurance standards.
Assist with initiating deviations (events) for components that do not meet specifications.
Assisting with corrective actions as a result of deviations and audit findings.
Oversee the implementation and efficiency of quality and inspection systems.
Collect and compile statistical quality data.
Facilitate and evaluate audit findings of internal audits.
Work independently on assigned projects.
Assist with the completion of corrective action tasks.
Support quality audits and document control.
Collaborate with other Quality staff to accomplish all daily tasks on-time and with a high level of quality.
Mentor Quality team members and share expertise.
Collaborate with other departments as needed on company processes.
Provide department specific orientation and training for new hires.
Identify training needs and organize training interventions to meet quality standards.
Drives Core Competency Model initiates in support of enhanced organizational performance.
Perform any other tasks/duties as assigned by management.