Specialist, Distribution Quality Assurance

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose

Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy.

Assess operations/distribution outages and deviations to determine compliance with specifications and procedures.

Responsibilities

• Approve/initiate changes to Distribution Operations and QA procedures, facility and equipment

• Audit Interface- FDA, supplier, customer inspection, corporate

• Conduct product quality, diversion and distribution complaint investigations

• Manage warehouse temperature monitoring program

• Initiate exceptions reports in the appropriate database

• Perform inbound quality inspections and usage decision

• Execute domestic and international sales/recall reports

• Execute placement and removal of QA Holds in warehouse management system

• Manage/Post supplier audit data in appropriate database

• Manage market authorization process and Material Data Management

Qualifications

• High school degree is required. Bachelor's degree is preferred

• 2-4 years in Quality Assurance, Process Support, Manufacturing, Distribution, Quality Control or similar area.

• Reviewing problem solving situation

• Understand manufacturing / distribution process

• Product responsibility for compliance troubleshooting

• Audit interface

• Creativity in resolving issues

• Negotiation skills with Mfg. / Distribution customers

Additional Information

Applicable only to applicants