Sr Quality System Specialist - Documentation (Hybrid)

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.

This position sits onsite at our North Chicago, IL headquarters 3 days weekly (2 days remote).

Purpose :

This position provides assurance of adherence to AbbVie documentation standards and principles. This role provides consultation and support to the global Research & Development organization on quality standards and processes including product documentation and the like.   This position serves as a subject matter expert for RDQA to strengthen the organization through assuring standards and quality for documentation and knowledge management.   Interfaces regularly with customer groups to resolve quality issues.

Responsibilities :

·          Provides clients with understanding of the AbbVie Quality System and its practical application.

·          Manages and leads global compliance and continuous improvement projects related to Quality System documentation.

·          Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.

·          Develops strategy for creation of complex QS procedural documents involving cross-functional teams.

·          Drives continuous improvement of Quality Documentation Standards

·          Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.

·          Provides training and assistance to R&D colleagues for documentation standards and documentation change control process when handling GxP documentation.

·          Provides support during audits and inspections.

·          Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM)

·          Maintains notifications, relations, and other property information within the Document Management System (DMS).

·          Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.

·          Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.

·          Collects and reports documentation-related key performance indicator metrics.

·          Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications :

·          Bachelor's degree (technical/scientific area preferred) or equivalent experience.

·          Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems

·          3-4 years’ experience using and administering electronic document management tools.

Specific Skills/Abilities

·          Basic understanding and knowledge of GxP requirements and pharmaceutical regulations preferred.

·          Advanced knowledge and hand-on experience with Document Management Systems OR other database applications

·          Advanced organizational skill, attention to detail

·          Experience with Microsoft Office products, incl MS Word processing / formatting experience

·          Advanced spoken and written English skills (OUS only))

·          Excellent verbal and written communication and interpersonal skills

·          Strong independent contributor and team member in a fast-paced environment.   Ability to work effectively in a team environment.

·          Builds strong relationships with peers and cross-functional partners to enable timeline completion of document lifecycle.

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.