AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco is seeking an experienced and highly motivated Senior Scientist I to join our Quality Control team focused on early stage (first in human through Ph 2 clinical) development.  The Quality Control team is responsible for a wide range of Quality Control GxP activities, including change management, document management, coordination of outsourced release and stability testing, shelf-life evaluation, preparation of Certificates of Analysis and coordination of the exception/quality event process.  In this role, you will represent the QC function on one or more program teams, with responsibility for authoring quality documents and regulatory submission sections. You will collaborate with Technical and Quality SMEs to achieve QC deliverables for release of GMP drug substance and drug product batches to enable clinical supply, as well as manage shelf-life assignment for clinical batches. Additionally, you will create and/or review change records and quality event records in support of GxP activities.

Responsibilities:

Key responsibilities include:

• Represent the QC function on cross functional program teams.
• Collaborate with analytical leads to achieve release and stability program deliverables.
• Author quality documents and regulatory submissions to enable regulatory submissions and clinical supply.
• Perform data verification.
• Trending of stability trending using JMP or other statistical software to support retest dating.
• Prepare and review quality control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports.
• Initiate and review change records in collaboration with Technical and Quality SMEs and stakeholders.
• Coordinate closely with document authors, owners, stakeholders and approvers in South San Francisco and other AbbVie sites to initiate and complete document workflows within target timelines.
• Ensure compliance with SOPs, standards, and requirements.
• Provide support during internal and external audits and inspections.

Serve as a subject matter expert for GxP quality system document management activities including: document formatting, document processing in the electronic document management system, document categorization/numbering nomenclature, and approval