Validation Specialist

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 www.abbvie.com.

Job Description

Purpose

Supports AbbVie's global quality assurance function, suppliers and manufacturing sites for medical devices and combination products by providing in-house support to ensure product meets customer and regulatory requirements. This position supports the analysis and data collection for product or quality system issues intended to support continuous improvement. This position will also be involved in the support of regulatory inspections for medical devices and combination products.

The employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

Responsibilities

• Quality Operations – Responsible for the processing and maintenance of SOPs for the business segment. Compiles quality data and trends for Quality Management and Product Reviews.
• Quality and Regulatory Compliance – Provides support and management of regulatory inspections and tracking inspectional responses. Training coordinator function responsibilities.
• Quality Systems – Maintains knowledge in both current and emerging GxP requirements and quality trends as they relate to Medical Device and Combination Products worldwide and supports and executes changes to quality standards / policies to ensure conformance.
• Organization Effectiveness and Strategic Direction – Types routine memos and letters, composes correspondence, schedules meetings, sets up filing systems, gathers information, answers questions on department and company policies and procedures, prepares basic reports, compiles statistics, and sets up databases.
• Assists with special projects, collecting and collating documents and materials as requested.
• Assists functional area, to compile and generate reports, timelines, correspondence and presentations.

Qualifications

Key Stakeholders

Development, Manufacturing, Quality and Regulatory

Additional Information

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

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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only – to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more : https : / / www.abbvie.com / join-us / reasonable-accommodations.html

J-18808-Ljbffr