Quality System Specialist II Documentation
1 month ago
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 II - 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:
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).
Minimum Qualifications:
• Bachelor's degree (technical/scientific area preferred) or equivalent experience.
• 1-2 years of pharmaceutical experience in a GMP environment administering Document Control Systems
• 1-2 years' experience using and administering electronic document management tools.
Other Required Skills:
• 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
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 an equal opportunity employer and 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.
US & Puerto Rico only - to learn more, visit
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Salary: $ $98000
-
Quality Assurance Analyst II
2 weeks ago
Chicago, Illinois, United States Techlink Systems Full timeJob OverviewPosition Title: Quality Assurance Analyst IILocation: Abbott Park, IL (Onsite)Contract Duration: 12 monthsSchedule: 8:00 AM - 4:00 PMClient: Abbott LaboratoriesJob ID: ABOJPWe provide medical, dental, vision, and 401(k) benefits after 90 days of employment.Position Summary:The Quality Assurance Analyst II is tasked with overseeing bioanalytical...
-
Document Management Specialist
15 hours ago
Chicago, Illinois, United States Dworkin and Maciariello Full timeJob SummaryThe Document Management Specialist plays a crucial role in overseeing the organization, maintenance, and accessibility of legal documents for Dworkin and Maciariello. This position requires a high level of attention to detail and organizational skills to ensure the accuracy and completeness of documents.Key ResponsibilitiesDocument Organization:...
-
Quality Assurance Engineer II
2 weeks ago
Chicago, Illinois, United States KYYBA Full timeJob OverviewPosition Title: Quality Assurance Engineer IIContract Duration: 6 months, with potential for extension Role Summary:As a Quality Assurance Engineer II, you will play a pivotal role in supporting the plant's Exception Report/CAPA System. Your responsibilities will include conducting thorough root cause analyses for any exceptions, nonconformities,...
-
Practical Nursing Specialist II
2 weeks ago
Chicago, Illinois, United States University of Illinois at Chicago Full timePosition Overview:The Practical Nursing Specialist II is responsible for providing comprehensive patient care under the supervision of a physician or registered nurse (RN), employing the Nursing Process and Relationship-Based Care framework.Key Responsibilities:The Practical Nursing Specialist II is dedicated to delivering direct patient care and actively...
-
Quality Enhancement Coordinator
7 days ago
Chicago, Illinois, United States UCAN (Chicago) Full timePosition Title: Quality Improvement Specialist I, II and IIIDepartment: Management and GeneralReports to: Vice President of Quality Improvement, Impact & Analysis Position Objective and Summary:The Quality Improvement Specialist plays a pivotal role in coordinating various program assessments, quality enhancement, and assurance activities within UCAN. This...
-
Systems Infrastructure Specialist II
2 weeks ago
Chicago, Illinois, United States McDonald's Corporation Full timeCompany OverviewAt McDonald's, our Accelerating the Arches strategy prioritizes our customers and employees, leveraging our unique strengths to enhance our brand. We are proud to be recognized on esteemed lists such as Fortune's Most Admired Companies and Fast Company's Most Innovative Companies.Focusing on the 4Ds (Delivery, Digital, Drive Thru, and...
-
Mobile Trailer Repair Specialist II
2 weeks ago
Chicago, Illinois, United States Cox Communications Full timeCompany Cox Automotive - USA Job Family Group Vehicle Operations Job Profile Mobile Trailer Repair Specialist II Management Level Individual Contributor Flexible Work Option Remote work is possible; however, residence in the designated city, state, or region is required. Travel % Yes, 100% travel required Work Shift Variable Compensation The hourly base pay...
-
Business Systems Analyst
7 days ago
Chicago, Illinois, United States Metropolitan Water Reclamation District of Greater Chicago Full timePosition Overview As a key contributor to the project team, you will engage in a variety of information technology initiatives aimed at enhancing business systems and operations. Serving as a liaison between business requirements and technical solutions, your role will include the preparation of project status updates for stakeholders. Key...
-
IT Business Systems Analyst
2 weeks ago
Chicago, Illinois, United States Metropolitan Water Reclamation District of Greater Chicago Full timePosition Overview As an integral part of the project team, you will engage in a variety of information technology initiatives aimed at enhancing business systems and operational functions. Serving as a liaison between business requirements and technical execution, your role will include generating project status updates for stakeholders. Key...
-
Security Operations Specialist II
2 weeks ago
Chicago, Illinois, United States Heartland Human Care Serv Full timePosition: Security Specialist IILocation: Heartland Human Care ServicesSchedule: Tuesday to Saturday (4:00pm-12:30am)Overview:Are you dedicated to safeguarding the welfare of at-risk individuals, including unaccompanied minors? We offer a rewarding opportunity for you to contribute significantly as a Security Specialist II (SS II) within our Youth...
-
Quality Enhancement Consultant
7 days ago
Chicago, Illinois, United States UCAN (Chicago) Full timePosition Title: Quality Improvement Specialist I, II and IIIDepartment: Management and GeneralReports to: Vice President of Quality Improvement, Impact & Analysis Position Objective and Summary:The Quality Improvement Specialist is tasked with overseeing various program evaluation, quality enhancement, and quality assurance activities within UCAN. This role...
-
Quality Enhancement Coordinator
7 days ago
Chicago, Illinois, United States UCAN (Chicago) Full timePosition Title: Quality Improvement Specialist I, II and IIIDepartment: Management and GeneralReports to: Vice President of Quality Improvement, Impact & Analysis Position Objective and Summary:The Quality Improvement Specialist is tasked with overseeing various program assessments, quality enhancement, and quality control functions within UCAN. This...
-
Computer Systems Technician
4 days ago
Chicago, Illinois, United States Metropolitan Water Reclamation District of Greater Chicago Full timeJob SummaryThe Metropolitan Water Reclamation District of Greater Chicago is seeking a skilled Desktop Support Specialist to join our team. As a key member of our IT department, you will be responsible for providing technical support and maintenance for our desktop environments.Key ResponsibilitiesDeploy and install applications to desktop environments,...
-
Business Systems Specialist
2 months ago
Chicago, Illinois, United States Center for Research in Security Prices (CRSP) Full timeGENERAL SUMMARY: The Business Systems Specialist's primary responsibilities are to gather business requirements, document business processes, define business rules, create test plans, and conduct tests. Collaboration with Application Developers, Technical Data Specialists, Market Data Analysts, and management is a large part of this responsibility. Since...
-
Documentation Specialist
1 week ago
North Chicago, Illinois, United States Manpower Group Inc. Full timeJob Summary:We are seeking a skilled Documentation Specialist to join our team at Manpower Group Inc. as a Content Creator and Technical Writer. In this role, you will be responsible for creating and modifying procedures related to our new Warehouse Management System, Manhattan.Key Responsibilities:Assist the team in developing and implementing documentation...
-
Production Systems Engineer II
2 weeks ago
Chicago, Illinois, United States Jabil Circuit, Inc. Full timeJOB SUMMARYThe Industrial Engineer II is tasked with the strategic planning, design, implementation, and oversight of integrated production and service delivery systems. This role is crucial in ensuring optimal performance, reliability, maintainability, adherence to schedules, and effective cost management within the production environment. The primary...
-
Quality Assurance Specialist
7 days ago
Chicago, Illinois, United States Actalent Full timeJob DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Quality Control: Perform wet chemistry lab analysis on raw materials, in-process, and finished products, including pH,...
-
Documentation Specialist
3 weeks ago
Chicago, Illinois, United States Orion Group Full timeLocation: Remote (8am - 4:30pm Central Time Zone)Contract Length: 6 Months (potential for extension)Pay Rate: $33-38/hr including individual healthcare coverage This position will be responsible for management of CMC and Device Post Approval Changes and Agency responses for company product portfolio. Job Requirements:Experience project managing marketed...
-
Quality Specialist Supply Chain
3 months ago
Chicago, Illinois, United States AbbVie Full timeCompany DescriptionAbbVie'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...
-
Security Operations Specialist II
7 days ago
Chicago, Illinois, United States Heartland Human Care Serv Full timePosition: Security Specialist IILocation: Heartland Human Care ServicesSchedule: Tuesday to Saturday (4:00pm-12:30am)Overview:Are you dedicated to safeguarding the well-being of at-risk individuals, including unaccompanied minors? This role as a Security Specialist II in Youth Residential Services at Heartland Human Care Services offers a unique opportunity...