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

We're seeking a skilled Patient Safety Operations Specialist (RN) to help maintain our commitment to excellence. As a Patient Safety Operations Specialist, you will ensure that all goals are met and that our practices and procedures comply with company policies. Responsible for maintaining compliance with FDA, AATB, and international and state regulations during the second-level quality review of all tissue donor files for tissue submitted to AbbVie to ensure the safety of donated human tissue. It will also support the triage and review of information received after the initial donor release to assess the potential impact on donor suitability and distributed products, triggering escalation procedures and evaluation for regulatory action.

Join our team of dedicated professionals and take your career to the next level. Apply now to become a part of our organization and help us maintain our commitment to excellence.

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

• Bachelor’s degree required in a scientific discipline or equivalent experience.

• 5+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry

• Demonstrated knowledge of and experience with quality systems, corrective action and preventive action system, and other key tools for managing global quality performance in a regulated industry.

• Ability to work in a multinational, multicultural and highly matrixed environment.

• Strong communication Skills, both oral and written

• Proficient in computer skills and hands on experience with database management, spreadsheets, project management, presentations, word processing, flowcharting and/or any other similar type of software.

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 a 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.