Quality Systems Specialist III

1 month 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

The Quality Systems Specialist III - Documentation, provides assurance of adherence to AbbVie documentation standards and principles. The role is primarily responsible for managing the creation and revision of Quality System and processes documents including assessment of proposed changes taking all controlled documentation and processes into account. Furthermore, acts as Subject Matter Expert for Quality documentation administration (Change Control) and is the interface between RDQA QS Documentation Management group and supported R&D functions.

Responsibilities:

Provides client with understanding of the AbbVie Quality System and its practical application.
Participates in 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.
Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
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).

Qualifications

Minimum Requirements:

Bachelors Degree (Technical/Scientific Area preferred)
Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems
1-2 years' experience using and administering electronic document management tools

Other Requirements:
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.
Detailed oriented with solid problem-solving acumen.

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.

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