Quality Control Scientist I – Biologics Analytical Research & Development
Posted on Sep 25, 2024 by AbbVie
South San Francisco, CA
Research
Immediate Start
Annual Salary
Full-Time
Job Description
AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco is seeking a highly motivated Scientist I to join our Quality Control team. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including document management, change management, coordination of outsourced release and stability testing, CoAs, shelf-life evaluation, and coordination of the exception/quality event process. In this role, your responsibilities will include GxP document preparation, processing, and management, data verification, and tracking of timelines and deliverables for release of GMP drug substance and drug product batches. You will be responsible for ensuring compliance with documentation standards, assist scientific and quality control staff with formatting of documents and completing impact assessments for document revisions. You will also provide support for additional quality control related organizational and administrative activities within the Biologics Analytical Research and Development Group.
Responsibilities:
Act 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 facilitation.
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.
Collaborate with external third-party GMP labs to obtain and archive TPL documents (including test methods, protocols, and reports) in AbbVie’s electronic document management system.
Prepare and/or assist in preparation of Quality Control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports.
May initiate and coordinate processing of change records in collaboration with Technical and Quality SMEs and stakeholders.
May gather and compile data from multiple source records to enable evaluation.
Organize & manage inventory of analytical development retain sample library.
Ensure compliance with SOPs, standards, and requirements.
Provide support during internal and external audits and inspections
Perform data verification for quality documents and regulatory submissions.
AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco is seeking a highly motivated Scientist I to join our Quality Control team. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including document management, change management, coordination of outsourced release and stability testing, CoAs, shelf-life evaluation, and coordination of the exception/quality event process. In this role, your responsibilities will include GxP document preparation, processing, and management, data verification, and tracking of timelines and deliverables for release of GMP drug substance and drug product batches. You will be responsible for ensuring compliance with documentation standards, assist scientific and quality control staff with formatting of documents and completing impact assessments for document revisions. You will also provide support for additional quality control related organizational and administrative activities within the Biologics Analytical Research and Development Group.
Responsibilities:
Act 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 facilitation.
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.
Collaborate with external third-party GMP labs to obtain and archive TPL documents (including test methods, protocols, and reports) in AbbVie’s electronic document management system.
Prepare and/or assist in preparation of Quality Control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports.
May initiate and coordinate processing of change records in collaboration with Technical and Quality SMEs and stakeholders.
May gather and compile data from multiple source records to enable evaluation.
Organize & manage inventory of analytical development retain sample library.
Ensure compliance with SOPs, standards, and requirements.
Provide support during internal and external audits and inspections
Perform data verification for quality documents and regulatory submissions.
Reference: 202390939
https://jobs.careeraddict.com/post/95560628
Quality Control Scientist I – Biologics Analytical Research & Development
Posted on Sep 25, 2024 by AbbVie
South San Francisco, CA
Research
Immediate Start
Annual Salary
Full-Time
Job Description
AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco is seeking a highly motivated Scientist I to join our Quality Control team. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including document management, change management, coordination of outsourced release and stability testing, CoAs, shelf-life evaluation, and coordination of the exception/quality event process. In this role, your responsibilities will include GxP document preparation, processing, and management, data verification, and tracking of timelines and deliverables for release of GMP drug substance and drug product batches. You will be responsible for ensuring compliance with documentation standards, assist scientific and quality control staff with formatting of documents and completing impact assessments for document revisions. You will also provide support for additional quality control related organizational and administrative activities within the Biologics Analytical Research and Development Group.
Responsibilities:
Act 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 facilitation.
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.
Collaborate with external third-party GMP labs to obtain and archive TPL documents (including test methods, protocols, and reports) in AbbVie’s electronic document management system.
Prepare and/or assist in preparation of Quality Control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports.
May initiate and coordinate processing of change records in collaboration with Technical and Quality SMEs and stakeholders.
May gather and compile data from multiple source records to enable evaluation.
Organize & manage inventory of analytical development retain sample library.
Ensure compliance with SOPs, standards, and requirements.
Provide support during internal and external audits and inspections
Perform data verification for quality documents and regulatory submissions.
AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco is seeking a highly motivated Scientist I to join our Quality Control team. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including document management, change management, coordination of outsourced release and stability testing, CoAs, shelf-life evaluation, and coordination of the exception/quality event process. In this role, your responsibilities will include GxP document preparation, processing, and management, data verification, and tracking of timelines and deliverables for release of GMP drug substance and drug product batches. You will be responsible for ensuring compliance with documentation standards, assist scientific and quality control staff with formatting of documents and completing impact assessments for document revisions. You will also provide support for additional quality control related organizational and administrative activities within the Biologics Analytical Research and Development Group.
Responsibilities:
Act 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 facilitation.
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.
Collaborate with external third-party GMP labs to obtain and archive TPL documents (including test methods, protocols, and reports) in AbbVie’s electronic document management system.
Prepare and/or assist in preparation of Quality Control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports.
May initiate and coordinate processing of change records in collaboration with Technical and Quality SMEs and stakeholders.
May gather and compile data from multiple source records to enable evaluation.
Organize & manage inventory of analytical development retain sample library.
Ensure compliance with SOPs, standards, and requirements.
Provide support during internal and external audits and inspections
Perform data verification for quality documents and regulatory submissions.
Reference: 202390939
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