Quality System Specialist, III â Documentation
Quality System Specialist, III â Documentation
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This position 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 Operations Documentation Management group and supports Operations PDS&T functions.
Responsibilities:
- 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 (DMS)
- Maintains notifications relations and other property information within the Document Management System (DMS).
- Participates in supporting Operations PDS&T projects initiatives and continuous improvement projects related to documentation management as applicable.
- Supports and coordinates document translation process as applicable.
- Provides input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).
- Represents Operations PDS&T on the Documentation Center of Excellence (COE)
- Administers and supports SharePoint
- Act as a records coordinator for PDS&T
- Acts as a validation coordinator for PDS&T
- Responsible for cataloging and arranging for off-site storage of physical records (RIMS)
- Responsible for driving records clean-up activities
Qualifications :
- Bachelors degree (technical/scientific area preferred) or equivalent experience.
- 1 - 2 years of pharmaceutical experience in a GMP environment administering Document Control Systems
- 2-4 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 hands-on experience with Document Management Systems
- Advanced organizational skills attention to detail
- Experience with Microsoft Office products incl MS Word processing / formatting experience
- 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 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
