AbbVie

Sr. Document Control Specialist

Employer
AbbVie
Location
Sunnyvale, CA, United States
Posted
Dec 17, 2020
Ref
2009400
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its 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 provides assurance of the adherence to documentation standards and Quality Knowledge Management principles. The 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:

• Act as SME for RDQA Bay Area for quality and compliance aspect in respect to Documentation Standards and Quality Knowledge Management, including related to Quality System documents and on cross functional teams and in meetings.

• Work on and lead special quality projects as assigned by Quality Management. Provide both training and assistance to site functions for documentation standards and document change controls when handling GxP documentation and product documents.

• Lead SOP development and update activities

• Demonstrate accuracy and proficiency in daily critical/analytical thinking and decision making

• Drive continuous improvement. Act as SME for RDQA Bay Area for quality and compliance aspects in respect to Documentation Standards and Quality Knowledge Management, including related QS document ownership, on cross-functional teams and in meetings.

• Lead, facilitate and participate in high-performing teams focused on initiatives on general documentation standards, quality knowledge management and Quality System / Product Documentation improvements.

• Ensure compliance to Standard Operating Procedures

• Perform document processing and records handling; accurate data entry into databases, as required.

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

• Accurately track, report, and analyze metrics, as required.

• A strong independent contributor who is a member of the Quality System team

Qualifications

Qualifications:

• Bachelor's degree required and 2-5 years minimum experience in Pharmaceutical Industry.

• 2 years' experience in using and administering electronic document management tools

• Demonstrates exceptional analytical and critical thinking skill and exceptional issue resolution skills.

• Working knowledge of Quality Systems, GMP-related requirements, and ICH guidelines, desirable

• Excellent verbal and written communication and interpersonal skills

• Prior experience participating (or leading) cross-functional projects and/or initiates.

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

• Demonstrate strong leadership, time management, multi-tasking, and organizational skills

• Prior experience in participating in cross-functional projects or initiatives.

• Proficient/advance knowledge of Microsoft Office suite

• Detailed oriented with solid problem-solving acumen

• Builds strong relationship with peers and cross-functional partners to enable higher performance

• Raises the bar and is never satisfied with status quo. Creates a learning environment, open to suggestions and experimentation to facilitate continuous improvement.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.