AbbVie Inc.
Location
South San Francisco, CA | United States
Job description
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 the Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure.
AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity for a Senior Document Management Specialist. As a document management specialist, you will work closely with drug development scientists, quality control staff, and document management colleagues at AbbVie sites in South San Francisco, Irvine, and Chicago to support a wide range of GxP document management and change management administrative activities. You will be responsible for processing GxP documents in the document management system and processing change management records in the quality system. You will be responsible for ensuring compliance with documentation standards, assist technical and quality control staff with formatting of documents and completing impact assessments for document revisions. You may also provide support for additional administrative and/or organizational activities within the Biologics Analytical Research and Development Group.
Responsibilities:
In this role, you will provide document management support for AbbVie’s Biologics Analytical Research and Development Organization. Key responsibilities include:
· Act as a subject matter expert for GxP quality system document management activities including: document formatting, document processing, document categorization/numbering nomenclature, and change request review and approval facilitation
· Process new, revised, retired GxP documents in the electronic document management system
· Process change management records in the quality system
· Ensure compliance with all documentation SOPs, standards, and requirements
· Assist with formatting of documents
· Facilitate the review and approval of new and revised documents
· Coordinate closely with document authors, owners, stakeholders and approvers to initiate and complete document and change record workflows within target timelines
· Provide support for retrieval of documents and records
· Provide support during internal and external audits and inspections
Requirements:
· Required: High School diploma or equivalent with 3+ years’ experience or Associate’s Degree. Preferred Education: Bachelor’s Degree
· Strong knowledge and hands-on experience with GxP electronic Document Management Systems
· Document management or related experience in the pharmaceutical/biopharmaceutical industry
· Experience in detail-intensive and customer-focused environments
· Excellent organizational skills, attention to detail, and strong verbal and written communications skills
· Must have a proactive approach, take initiative, and independently follow through with responsibilities.
· Advanced word processing knowledge and experience with Microsoft Office products
· Must have ability to communicate effectively with customers and stakeholders, including scientists, quality control staff, and quality assurance partners.
· Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment.
· Able to work independently and as part of a team
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 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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