Specialist Distribution Quality Assurance

4 weeks ago

Chicago, Illinois, United States AbbVie Full time

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 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 applying to a position in any location with pay disclosure requirements under state or local law: ​

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ​
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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