Quality Systems Specialist Iii - North Chicago, United States - AbbVie

AbbVie

Verified Company

North Chicago, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Company 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:

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 crossfunctional 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 documentationrelated 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
12 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 handon experience with Document Management Systems OR other
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 fastpaced environment. Ability to work

effectively in a team environment.

Builds strong relationships with peers and crossfunctional partners to enable timeline

completion of document lifecycle.

Detailed oriented with solid problemsolving acumen.

Additional Information

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 shortterm 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.